TY - JOUR AU - Burhan, Erlina AU - Azzumar, Farchan AU - Sinuraya, Gabriella Fira Alyssa AU - Rakasiwi, Dhiya Muhammad Ilham AU - Akbar, Ihya AU - Mubarak, Farhan AU - Rengganis, Tresna Anggit AU - Rachmadi, Abi Rizky AU - Afidjati, Hera PY - 2025/4/10 TI - Real-World Effectiveness of COVID-19 Vaccines (ChAdOx-1s, CoronaVac, BBIBP-CorV, mRNA-1273, and BNT162b2) in Jakarta: Protocol for Test-Negative Design of Health Care Data JO - JMIR Res Protoc SP - e56519 VL - 14 KW - COVID-19 KW - protocol KW - vaccine KW - vaccine effectiveness KW - Delta KW - Omicron N2 - Background: ChAdOx-1s, CoronaVac, BBIBP-CorV, mRNA-1273, and BNT162b2 are the five common COVID-19 vaccines used in Jakarta. Randomized controlled trials have provided robust evidence of the safety and efficacy profile of these vaccines, but their real-world vaccine effectiveness against symptomatic COVID-19 and deaths in communities with social inequalities and health care constraints remains unclear. Objective: This study aims to evaluate the real-world effectiveness of these COVID-19 vaccines during the waves associated with the Delta and Omicron variants by analyzing existing electronic health care sources. Methods: A population-based study with a test-negative case-control design will be used to evaluate COVID-19 vaccine effectiveness in Jakarta, focusing on the Delta and Omicron waves. It includes adults 18 years and older who underwent reverse transcription polymerase chain reaction testing for symptomatic COVID-19, classifying them as cases or controls based on their test results. The analysis will consider multiple COVID-19 vaccines introduced during these periods, with participants categorized by vaccination status. Several potential confounders will be assessed, including demographic factors and comorbidities. Data will be linked from various health datasets, and statistical analyses will be performed to determine vaccine effectiveness and potential waning immunity over time. After data linkage, patients? identities will be encrypted. Results: The research, funded from 2022 to 2024, involved proposal preparation and ethical review in 2023 and enrollment from early 2024 to July 2024, resulting in about 4 million linked data points. Data analysis is ongoing, with initial results expected for publication in early 2025. Conclusions: This study will be the first to evaluate the effectiveness of different types of COVID-19 vaccines (inactivated, viral-vector, and mRNA) used in Jakarta during the pandemic, providing valuable scientific evidence to inform future vaccination strategies in the country. International Registered Report Identifier (IRRID): DERR1-10.2196/56519 UR - https://www.researchprotocols.org/2025/1/e56519 UR - http://dx.doi.org/10.2196/56519 UR - http://www.ncbi.nlm.nih.gov/pubmed/39902869 ID - info:doi/10.2196/56519 ER - TY - JOUR AU - Rotondo, Jenny AU - VanSteelandt, Amanda AU - Kouyoumdjian, Fiona AU - Bowes, J. Matthew AU - Kakkar, Tanya AU - Jones, Graham AU - Abele, Brandi AU - Murray, Regan AU - Schleihauf, Emily AU - Halverson, Jessica AU - Leason, Jennifer AU - Huyer, Dirk AU - Jackson, Beth AU - Bozat-Emre, Songul AU - Shah, Devanshi AU - Rees, E. Erin PY - 2025/4/10 TI - Substance-Related Acute Toxicity Deaths in Canada From 2016 to 2017: Protocol for a Retrospective Chart Review Study of Coroner and Medical Examiner Files JO - JMIR Public Health Surveill SP - e49981 VL - 11 KW - acute toxicity KW - Canada KW - chart review study KW - coroner KW - death investigations KW - drug overdose KW - medical examiner KW - mortality KW - poisoning KW - protocol N2 - Background: Canada continues to experience a national overdose crisis. While studies are available at the regional, provincial, and territorial levels, detailed national data regarding the burden and context of substance-related acute toxicity deaths are limited, particularly in subpopulations. In response to the overdose crisis, the Public Health Agency of Canada, in collaboration with provincial and territorial ministries of health and chief coroner and chief medical examiner offices, has undertaken a national chart review study. Objective: This study was conducted to describe and compare the characteristics of substance-related acute toxicity deaths that occurred in Canada between 2016 and 2017, including descriptions of those who died, the substances involved, and the circumstances surrounding their deaths. This paper describes the study methodology in detail. Methods: This retrospective, population-based, and cross-sectional study involved the review of coroner and medical examiner files for deaths that met the study case definition. Data were collected on demographic and socioeconomic characteristics, medical and substance use history, proximal circumstances surrounding the death, and toxicology findings using a standardized data collection tool that underwent 2 pilot studies. Data abstractors underwent training and regular intrarater reliability exercises with a fictitious death investigation file. Data quality was assessed based on the consistency of abstractor intrarater reliability scores and the completeness of core variables and variables for key concepts. Data were linked to national datasets to allow for the examination of area-level geographic and socioeconomic characteristics. Descriptive analyses will examine differences across subpopulations and the general Canadian population. Latent class, spatiotemporal, qualitative, and premature death analyses are also planned. Where possible, analyses will be stratified by the manner of death and sex. Results: The study began in the summer of 2018, and abstraction was delayed due to the COVID-19 pandemic. All activities are expected to be completed by early 2025. A total of 9414 coroner and medical examiner files met the study case definition. Most abstractors (25/26, 96%) met the established threshold for consistency throughout abstraction without the need for remedial training. In general, core study variables, including geographic variables and substances contributing to death, had very good availability. Study variables related to the person?s health, history of substance use, and events surrounding the acute toxicity event were available for most records. Socioeconomic variables and variables describing socially constructed identities and potentially traumatic life events were mostly unavailable. Conclusions: This study provides the most detailed national information on substance-related acute toxicity deaths in Canada to date and can serve as a pre?COVID-19 pandemic baseline for assessing the evolution of the overdose crisis. Results can inform policies and programs to address the overdose crisis, the development of common approaches to medicolegal death investigations, and future research activities. UR - https://publichealth.jmir.org/2025/1/e49981 UR - http://dx.doi.org/10.2196/49981 UR - http://www.ncbi.nlm.nih.gov/pubmed/40208661 ID - info:doi/10.2196/49981 ER - TY - JOUR AU - Roberts, T. Sarah AU - Minnis, M. Alexandra AU - Napierala, Sue AU - Montgomery, T. Elizabeth AU - Digolo, Lina AU - Cottrell, L. Mackenzie AU - Browne, N. Erica AU - Ndirangu, Jacqueline AU - Boke, Joyce AU - Agot, Kawango PY - 2025/4/1 TI - Evaluation of the Tu?Washindi Na PrEP Intervention to Reduce Gender-Based Violence and Increase Preexposure Prophylaxis Uptake and Adherence Among Kenyan Adolescent Girls and Young Women: Protocol for a Cluster Randomized Controlled Trial JO - JMIR Res Protoc SP - e55931 VL - 14 KW - adolescent girls and young women KW - HIV prevention KW - preexposure prophylaxis KW - PrEP KW - adherence KW - Kenya KW - intimate partner violence N2 - Background: Adolescent girls and young women constitute a priority population disproportionately affected by HIV, accounting for 25% of annual HIV incidence among people older than 15 years in Kenya. Although oral preexposure prophylaxis (PrEP) is effective in reducing HIV acquisition, its protective benefit has been limited among adolescent girls and young women in sub-Saharan Africa because of low uptake, adherence, and persistence. Intimate partner violence (IPV) and relationship power inequities are widespread among adolescent girls and young women and contribute to higher HIV incidence and lower PrEP use. Interventions are needed to support sustained PrEP use among adolescent girls and young women by addressing IPV and relationship dynamics. Objective: This study aims to test the effectiveness of Tu?Washindi na PrEP (?We are Winners with PrEP?), a multilevel community-based intervention, to increase uptake and adherence to PrEP and reduce IPV among adolescent girls and young women in Siaya County, Kenya. Methods: The Tu?Washindi na PrEP intervention was co-designed by our team and adolescent girls and young women using participatory methods and includes 3 components delivered over 6 months: an 8-session, empowerment-based support club for adolescent girls and young women, community sensitization targeted toward male partners, and PrEP education events for couples. The intervention will be evaluated using a cluster randomized controlled trial across 22 administrative wards in Siaya County, Kenya, enrolling 72 adolescent girls and young women per ward (total N=1584). The primary objectives are to test the effectiveness of the intervention on PrEP uptake and adherence immediately after delivery (month 6 after enrollment) and 6 months later (month 12). As secondary objectives, we will test the intervention effect on IPV. A rigorous process evaluation will explore mechanisms of change, contextual factors, and implementation considerations to inform future refinement and scale-up, using programmatic data, participant questionnaires, and qualitative interviews with participants and intervention providers. Results: Data collection started in September 2022. As of December 2024, enrollment has been completed in 16 of the 22 study wards, with 72.6% (1150/1584) of participants enrolled. We anticipate that data collection will be completed in May 2026 and results will be available by mid-2027. Conclusions: The study builds directly on our promising formative and pilot research to develop the evidence base for this youth-designed, multilevel HIV prevention intervention. If effective, Tu?Washindi will be ideally positioned for sustainable integration into existing youth-focused programming to expand and support PrEP use in this priority population. Trial Registration: ClinicalTrials.gov NCT05599581; https://www.clinicaltrials.gov/study/NCT05599581 International Registered Report Identifier (IRRID): DERR1-10.2196/55931 UR - https://www.researchprotocols.org/2025/1/e55931 UR - http://dx.doi.org/10.2196/55931 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/55931 ER - TY - JOUR AU - Mathew, Jenny AU - Pagliaro, A. Jaclyn AU - Elumalai, Sathyanarayanan AU - Wash, K. Lauren AU - Ly, Ka AU - Leibowitz, J. Alison AU - Vimalananda, G. Varsha PY - 2025/3/27 TI - Developing a Multisensor-Based Machine Learning Technology (Aidar Decompensation Index) for Real-Time Automated Detection of Post?COVID-19 Condition: Protocol for an Observational Study JO - JMIR Res Protoc SP - e54993 VL - 14 KW - Aidar Decompensation Index KW - AIDI KW - biophysical biomarkers of worsening health KW - biosensor-based physiological monitoring KW - cardiorespiratory, metabolic, renal, and neurological complications after COVID-19 KW - early warning signs of clinical decompensation KW - long COVID KW - noninvasive monitoring of physiology KW - postacute sequelae of COVID-19 KW - PACS KW - rapid assessment tool KW - risk triaging related to long COVID N2 - Background: Post?COVID-19 condition is emerging as a new epidemic, characterized by the persistence of COVID-19 symptoms beyond 3 months, and is anticipated to substantially alter the lives of millions of people globally. Patients with severe episodes of COVID-19 are significantly more likely to be hospitalized in the following months. The pathophysiological mechanisms for delayed complications are still poorly understood, with a dissociation seen between ongoing symptoms and objective measures of cardiopulmonary health. COVID-19 is anticipated to alter the long-term trajectory of many chronic cardiovascular and pulmonary diseases, which are common among those at risk of severe disease. Objective: This study aims to use a single, integrated device?MouthLab, which measures 10 vital health parameters in 60 seconds?and a cloud-based proprietary analytics engine to develop and validate the Aidar Decompensation Index (AIDI), to predict decompensation in health among patients who previously had severe COVID-19. Methods: Overall, 200 participants will be enrolled. Inclusion criteria are patients in the US Department of Veterans Affairs health care system; ?severe? COVID-19 infection during the acute phase, defined as requiring hospitalization, within 3-6 months before enrollment; aged ?18 years; and having 1 of 6 prespecified chronic conditions. All participants will be instructed to use the MouthLab device to capture daily physiological data and complete monthly symptom surveys. Structured data collection tables will be developed to extract the clinical characteristics of those who experience decompensation events (DEs). The performance of the AIDI will depend on the magnitude of difference in physiological signals between those experiencing DEs and those who do not, as well as the time until a DE (ie, the closer to the event, the easier the prediction). Information about demographics, symptoms (Medical Research Council Dyspnea Scale and Post-COVID-19 Functional Status Scale), comorbidities, and other clinical characteristics will be tagged and added to the biomarker data. The resultant predicted probability of decompensation will be translated into the AIDI, where there will be a linear relationship between the risk score and the AIDI. To improve prediction accuracy, data may be stratified based on biological sex, race, ethnicity, or underlying clinical characteristics into subgroups to determine if there are differences in performance and detection lead times. Using appropriate algorithmic techniques, the study expects the model to have a sensitivity of >80% and a positive predicted value of >70%. Results: Recruitment began in January 2023, and at the time of manuscript submission, 204 patients have been enrolled. Publication of the complete results and data from the study is expected in 2025. Conclusions: The focus on identifying predictor variables using a combination of biosensor-derived physiological features should enable the capture of heterogeneous characteristics of complications related to post?COVID-19 condition across diverse populations. Trial Registration: ClinicalTrials.gov NCT05220306; https://clinicaltrials.gov/study/NCT05220306 UR - https://www.researchprotocols.org/2025/1/e54993 UR - http://dx.doi.org/10.2196/54993 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/54993 ER - TY - JOUR AU - Rainer, Crissi AU - Schnall, Rebecca AU - Tanner, R. Mary AU - Galindo, A. Carla AU - Hoover, W. Karen AU - Naar, Sylvie AU - Brin, Maeve AU - Martinez, Andres AU - Jia, Haomiao AU - Mendoza, Maria AU - Hightow-Weidman, Lisa PY - 2025/3/20 TI - Developing and Implementing Provider-Training and Evidence-Based Tools to Support Pre-exposure Prophylaxis (PrEP) Decision-Making and Increase PrEP Adherence Among Young Men Who Have Sex With Men: Protocol for the PrEP Choice Longitudinal Cohort Study JO - JMIR Res Protoc SP - e64186 VL - 14 KW - pre-exposure prophylaxis KW - PrEP KW - PrEP cohort KW - young men who have sex with men KW - YMSM KW - digital health KW - evidence-based tools KW - motivational interviewing N2 - Background: Despite the availability of highly effective HIV pre-exposure prophylaxis (PrEP), uptake and adherence to PrEP among young men who have sex with men (YMSM) remains low, limiting its impact on the prevention of HIV infection. Strategies that incorporate an array of prevention options and provide YMSM and their providers with tailored education and support tools, including tools to support shared decision-making, are needed. Objective: The goals of the Centers for Disease Control and Prevention (CDC)?funded PrEP Choice study include the development and deployment of CDC guideline?consistent PrEP provider training and the implementation of evidence-based provider- and client-facing PrEP education and support tools. Under this initiative, the CDC funded 2 research projects, Florida State University (the Expanding PrEP in Communities of Color [EPICC] project), and Columbia University (the mChoice project). Methods: Providers from both projects will complete the PrEP Choice online training, which was developed to educate providers on PrEP options and how to engage clients in open discussions around sexual health and PrEP options. EPICC project providers will also attend online tailored motivational interviewing (TMI) training sessions, and mChoice project providers will view a training video on cultural competency and humility in PrEP care. Following training, each project will enroll a cohort of 400 participants receiving care from study providers and follow them for 12-18 months. Participants will complete online surveys every 3 months and provide biomarkers to assess PrEP adherence. Electronic health record (EHR) data will be collected every 6 months to provide additional information on clinic attendance, PrEP prescriptions, and HIV/sexually transmitted infection (STI) testing. Each project will provide cohort participants with a unique digital health tool to support the PrEP choice and ongoing adherence. The study will assess the effectiveness of training and educational and support tools in practice and the critical factors associated with the successful uptake of and adherence to PrEP by participants. The study will also monitor patterns of PrEP use among YMSM, including types of PrEP and switching between types. Results: Formative work to develop and prepare the tools for implementation was completed in 2023. The EPICC project began provider training in early 2024, and the mChoice project began in spring 2024. Cohort enrollment for both projects began after provider training began. Conclusions: Given the changing PrEP landscape, implementation of provider education and tools to maximize uptake and adherence is needed. By delivering culturally competent and interactive provider training on PrEP options, the study will help providers counsel and guide participants on the effective and safe use of PrEP. The digital health tools created will support participant adherence to help them optimize PrEP benefits. Through the cohort design, the PrEP Choice study will provide real-world data about PrEP use that will be critical for informing future guidelines and tools. International Registered Report Identifier (IRRID): DERR1-10.2196/64186 UR - https://www.researchprotocols.org/2025/1/e64186 UR - http://dx.doi.org/10.2196/64186 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/64186 ER - TY - JOUR AU - Nijhawan, E. Ank AU - Kholy, Jana AU - Marcus, L. Julia AU - Hogan, P. Timothy AU - Higashi, T. Robin AU - Naeem, Jacqueline AU - Hansen, Laura AU - Torres, Brynn AU - Harris, Barry-Lewis AU - Zhang, Song AU - Krakower, Douglas PY - 2025/3/18 TI - A Multicomponent Strategy to Improve HIV Pre-Exposure Prophylaxis in a Southern US Jail: Protocol for a Type 3 Hybrid Implementation-Effectiveness Trial JO - JMIR Res Protoc SP - e64813 VL - 14 KW - pre-exposure prophylaxis KW - PrEP KW - HIV KW - HIV prevention KW - jail KW - incarceration KW - health disparity KW - electronic health records KW - EHR KW - southern United States N2 - Background: Pre-exposure prophylaxis (PrEP) is an effective approach for preventing HIV infection, but it is underutilized by populations who may benefit the most, including people living in the Southern United States and those involved in the criminal legal (CL) system. Improving the access and use of PrEP for these groups could decrease HIV-related health disparities. Beyond individual outcomes, HIV prevention for CL-involved people can have a significant public health impact on HIV incidence due to a high turnover between jails and the community. Objective: We will develop, implement, and evaluate a multicomponent PrEP implementation strategy for the Dallas County Jail (DCJ) to increase the initiation of this HIV-preventive intervention for CL-involved individuals. Methods: This is a type 3 hybrid implementation-effectiveness study that takes a combined approach by assessing the implementation of a strategy to identify candidates for PrEP at the DCJ and linking them to PrEP providers upon community re-entry while also gathering information about clinical outcomes. The approach is guided by the EPIS (exploration, preparation, implementation, sustainment) framework. Initial formative work (exploration) involves qualitative interviews of diverse key stakeholders to identify factors that may influence linkage to PrEP after jail release. These findings will undergo rapid qualitative analysis (preparation) to inform the adaptation of a multicomponent jail PrEP implementation strategy protocol. This approach, which will include an electronic health record (EHR) prediction model and integration of a PrEP patient navigator into the jail health team, will allow medical providers and the navigator at the DCJ to engage individuals most likely to benefit in shared decision-making about PrEP and navigate them to community PrEP care (implementation) in a process that begins before release from jail and ends with successful care linkage. Regular quantitative and qualitative evaluations of this approach will allow for ongoing stakeholder input, refinement of the implementation strategy, and maintenance of the program (sustainment). Results: Findings from 26 qualitative interviews (9 formerly incarcerated individuals, 9 county jail staff, and 8 employees of community organizations) have been obtained, analyzed, and mapped to an implementation strategy formalized in a jail PrEP protocol. An HIV risk prediction model based on EHR data to identify individuals most likely to benefit from PrEP has been developed and internally validated and is ready to be deployed. We anticipate the availability of preliminary study findings in 2026. Conclusions: This study will provide key insights into the feasibility and effectiveness of a PrEP implementation strategy among people at increased risk of HIV acquisition in an urban jail in Southern United States. This practical and scalable strategy can be used as a model for other urban jails to address HIV-related inequities. International Registered Report Identifier (IRRID): DERR1-10.2196/64813 UR - https://www.researchprotocols.org/2025/1/e64813 UR - http://dx.doi.org/10.2196/64813 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/64813 ER - TY - JOUR AU - Draucker, Burke Claire AU - Carrión, Andrés AU - Ott, A. Mary AU - Hicks, I. Ariel AU - Knopf, Amelia PY - 2025/2/13 TI - A 4-Site Public Deliberation Project on the Acceptability of Youth Self-Consent in Biomedical HIV Prevention Trials: Assessment of Facilitator Fidelity to Key Principles JO - JMIR Form Res SP - e58451 VL - 9 KW - public deliberation KW - deliberative democracy KW - bioethics KW - ethical conflict KW - biomedical KW - HIV prevention KW - HIV research KW - group facilitation KW - fidelity assessment KW - content analysis N2 - Background: Public deliberation is an approach used to engage persons with diverse perspectives in discussions and decision-making about issues affecting the public that are controversial or value laden. Because experts have identified the need to evaluate facilitator performance, our research team developed a framework to assess the fidelity of facilitator remarks to key principles of public deliberation. Objective: This report describes how the framework was used to assess facilitator fidelity in a 4-site public deliberation project on the acceptability of minor self-consent in biomedical HIV prevention research. Methods: A total of 88 individuals participated in 4 deliberation sessions held in 4 cities throughout the United States. The sessions, facilitated by 18 team members, were recorded and transcribed verbatim. Facilitator remarks were highlighted, and predetermined coding rules were used to code the remarks to 1 of 6 principles of quality deliberations. A variety of display tables were used to organize the codes and calculate the number of facilitator remarks that were consistent or inconsistent with each principle during each session across all sites. A content analysis was conducted on the remarks to describe how facilitator remarks aligned or failed to align with each principle. Results: In total, 735 remarks were coded to one of the principles; 516 (70.2%) were coded as consistent with a principle, and 219 (29.8%) were coded as inconsistent. A total of 185 remarks were coded to the principle of equal participation (n=138, 74.6% as consistent; n=185, 25.4% as inconsistent), 158 were coded to expression of diverse opinions (n=110, 69.6% as consistent; n=48, 30.4% as inconsistent), 27 were coded to respect for others (n=27, 100% as consistent), 24 were coded to adoption of a societal perspective (n=11, 46% as consistent; n=13, 54% as inconsistent), 99 were coded to reasoned justification of ideas (n=81, 82% as consistent; n=18, 18% as inconsistent), and 242 were coded to compromise or movement toward consensus (n=149, 61.6% as consistent; n=93, 38.4% as inconsistent). Therefore, the counts provided affirmation that most of the facilitator remarks were aligned with the principles of deliberation, suggesting good facilitator fidelity. By considering how the remarks aligned or failed to align with the principles, areas where facilitator fidelity can be strengthened were identified. The results indicated that facilitators should focus more on encouraging quieter members to participate, refraining from expressing personal opinions, promoting the adoption of a societal perspective and reasoned justification of opinions, and inviting deliberants to articulate their areas of common ground. Conclusions: The results provide an example of how a framework for assessing facilitator fidelity was used in a 4-site deliberation project. The framework will be refined to better address issues related to balancing personal and public perspectives, managing plurality, and mitigating social inequalities. UR - https://formative.jmir.org/2025/1/e58451 UR - http://dx.doi.org/10.2196/58451 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/58451 ER - TY - JOUR AU - Zhang, Kehe AU - Hunyadi, V. Jocelyn AU - de Oliveira Otto, C. Marcia AU - Lee, Miryoung AU - Zhang, Zitong AU - Ramphul, Ryan AU - Yamal, Jose-Miguel AU - Yaseen, Ashraf AU - Morrison, C. Alanna AU - Sharma, Shreela AU - Rahbar, Hossein Mohammad AU - Zhang, Xu AU - Linder, Stephen AU - Marko, Dritana AU - Roy, White Rachel AU - Banerjee, Deborah AU - Guajardo, Esmeralda AU - Crum, Michelle AU - Reininger, Belinda AU - Fernandez, E. Maria AU - Bauer, Cici PY - 2025/2/11 TI - Increasing COVID-19 Testing and Vaccination Uptake in the Take Care Texas Community-Based Randomized Trial: Adaptive Geospatial Analysis JO - JMIR Form Res SP - e62802 VL - 9 KW - COVID-19 testing KW - COVID-19 vaccination KW - study design KW - community-based interventions KW - geospatial analysis KW - public health KW - social determinants of health KW - data dashboard N2 - Background: Geospatial data science can be a powerful tool to aid the design, reach, efficiency, and impact of community-based intervention trials. The project titled Take Care Texas aims to develop and test an adaptive, multilevel, community-based intervention to increase COVID-19 testing and vaccination uptake among vulnerable populations in 3 Texas regions: Harris County, Cameron County, and Northeast Texas. Objective: We aimed to develop a novel procedure for adaptive selections of census block groups (CBGs) to include in the community-based randomized trial for the Take Care Texas project. Methods: CBG selection was conducted across 3 Texas regions over a 17-month period (May 2021 to October 2022). We developed persistent and recent COVID-19 burden metrics, using real-time SARS-CoV-2 monitoring data to capture dynamic infection patterns. To identify vulnerable populations, we also developed a CBG-level community disparity index, using 12 contextual social determinants of health (SDOH) measures from US census data. In each adaptive round, we determined the priority CBGs based on their COVID-19 burden and disparity index, ensuring geographic separation to minimize intervention ?spillover.? Community input and feedback from local partners and health workers further refined the selection. The selected CBGs were then randomized into 2 intervention arms?multilevel intervention and just-in-time adaptive intervention?and 1 control arm, using covariate adaptive randomization, at a 1:1:1 ratio. We developed interactive data dashboards, which included maps displaying the locations of selected CBGs and community-level information, to inform the selection process and guide intervention delivery. Selection and randomization occurred across 10 adaptive rounds. Results: A total of 120 CBGs were selected and followed the stepped planning and interventions, with 60 in Harris County, 30 in Cameron County, and 30 in Northeast Texas counties. COVID-19 burden presented substantial temporal changes and local variations across CBGs. COVID-19 burden and community disparity exhibited some common geographical patterns but also displayed distinct variations, particularly at different time points throughout this study. This underscores the importance of incorporating both real-time monitoring data and contextual SDOH in the selection process. Conclusions: The novel procedure integrated real-time monitoring data and geospatial data science to enhance the design and adaptive delivery of a community-based randomized trial. Adaptive selection effectively prioritized the most in-need communities and allowed for a rigorous evaluation of community-based interventions in a multilevel trial. This methodology has broad applicability and can be adapted to other public health intervention and prevention programs, providing a powerful tool for improving population health and addressing health disparities. UR - https://formative.jmir.org/2025/1/e62802 UR - http://dx.doi.org/10.2196/62802 ID - info:doi/10.2196/62802 ER - TY - JOUR AU - Savaria, Virginie AU - Queenton, Johanne AU - Carrier, Annie PY - 2025/1/17 TI - Decentralized Management of Home Care Services for Seniors: Protocol for a Participatory Action Research JO - JMIR Res Protoc SP - e58271 VL - 14 KW - health system KW - decentralization KW - management KW - home care services KW - seniors KW - collaboration N2 - Background: The centralization of decision-making power in the public health care system has a negative impact on the practice of professionals and the quality of home care services (HCS) for seniors. To improve HCS, decentralized management could be a particularly promising approach. To be effective, strategies designed to incorporate this management approach require attention to 3 elements: autonomy of local stakeholders, individual and organizational capacities, and accountability for actions and decisions. Not many studies have focused on strategies for integrating decentralized and collaborative management at the local level in HCS. Objective: The overall aim of this study is to coconstruct HCS management strategies and explore decentralized practices in the day-to-day work of low-level managers and professionals. The specific objectives, in collaboration with local HCS stakeholders, are to (1) identify concrete and achievable strategies for decentralized management, and (2) describe factors (facilitators and obstacles) that could potentially influence their integration. Methods: This participatory action research involves a cyclical process. Before initiating the cycles, a preliminary stage consists of forming a steering committee composed of managers (n=3), professionals (n=3), seniors (n=3), informal caregivers (n=3), and the research team (n=3). This committee will facilitate multistakeholder consultation to coconstruct local management strategies based on a real-life problem identified by the committee. The steering committee will also guide the research process. The first cycle will consist of establishing an initial plan of decentralized management strategies. During the observation phase, meetings of 4 homogeneous focus groups, including managers, professionals, seniors, and informal caregivers, will be held. During the reflection phase, a thematic analysis will be carried out, and data will be interpreted and validated by the steering committee. Then, in the action phase, results will be presented to managers and professionals so that they can coconstruct a plan of decentralized management strategies to prioritize. The second cycle will explore the factors involved. The observation, reflection, and action phases will be repeated. Ultimately, the results of the 2 cycles will be integrated in a model coconstructed by the steering committee. Results: Data collection is in progress; the partnership officially began on February 1, 2024, and the plan is to continue data collection through 2025. The steering committee will validate the data to ensure that they are accurate and that the results reflect the reality of local stakeholders. Conclusions: By identifying decentralized and collaborative management strategies at the local level as well as factors to facilitate their integration in HCS, this approach can be used for other decentralized management projects in different areas of the health care system. This study will give decision makers insight into strategies aimed at improving the management of their institution, which will enhance seniors? well-being and the quality of their health care services. International Registered Report Identifier (IRRID): DERR1-10.2196/58271 UR - https://www.researchprotocols.org/2025/1/e58271 UR - http://dx.doi.org/10.2196/58271 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/58271 ER - TY - JOUR AU - Buetti, David AU - Larche, Cynthia AU - Fitzgerald, Michael AU - Bourgeois, Isabelle AU - Cameron, Erin AU - Carr, Kady AU - Aubry, Tim AU - Persaud, Sydney AU - Kendall, E. Claire PY - 2025/1/17 TI - Evaluating the Impacts of Community-Campus Engagement on Population Health in Ottawa and Thunder Bay, Canada: Protocol for a Mixed Methods Contribution Analysis JO - JMIR Res Protoc SP - e58546 VL - 14 KW - community-campus engagement KW - population health KW - contribution analysis KW - mixed methods KW - health determinants KW - community health KW - CityStudio KW - theory of change KW - impact evaluation N2 - Background: Municipalities play a crucial role in population health due to their community connections and influence on health determinants. Community-campus engagement (CCE), that is, collaboration between academic institutions and communities, is a promising approach to addressing community health priorities. However, evidence of CCE?s impact on population health remains limited. Measuring the impacts of CCE is inherently complex due to factors such as diverse stakeholders, context-specific variables, and dynamic interactions within a community. Objective: This study aims to develop robust evidence on the impacts of CCE on population health outcomes in Ottawa and Thunder Bay, Ontario, Canada, focusing on 5 shared health priorities: housing, discrimination, poverty, violence, and mental health. Methods: We will use a proven CCE model called CityStudio, which has been implemented in both cities. We will use Mayne's mixed methods contribution analysis in three stages: (1) formulating a theory of change that outlines the expected contributions of CCE to population health outcomes; (2) gathering qualitative and quantitative data in line with the established Theory of Change; the data will be collected from various sources, including case studies of existing CityStudio projects, a web-based CCE stakeholder survey, a literature review, and population and community health data; and (3) reviewing the gathered evidence to determine the extent of CCE impacts on population health. Results: Ethical approval for this project was granted in May 2023. We have since initiated stage 1 by reviewing the literature to inform the development of the theory of change. We expect to complete this study by May 2026. Conclusions: This study will address two critical gaps about how improving health outcomes depends on CCE: (1) how academic institutions can best engage with their communities to improve population health outcomes, and (2) how municipalities can engage with academic institutions to address their community health priorities. Conducting our work in differing contexts will allow us to consider a broader range of other influences on outcomes, thus making our work applicable to various settings and outcomes. International Registered Report Identifier (IRRID): PRR1-10.2196/58546 UR - https://www.researchprotocols.org/2025/1/e58546 UR - http://dx.doi.org/10.2196/58546 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/58546 ER - TY - JOUR AU - Atchison, J. Christina AU - Gilby, Nicholas AU - Pantelidou, Galini AU - Clemens, Sam AU - Pickering, Kevin AU - Chadeau-Hyam, Marc AU - Ashby, Deborah AU - Barclay, S. Wendy AU - Cooke, S. Graham AU - Darzi, Ara AU - Riley, Steven AU - Donnelly, A. Christl AU - Ward, Helen AU - Elliott, Paul PY - 2025/1/9 TI - Strategies to Increase Response Rate and Reduce Nonresponse Bias in Population Health Research: Analysis of a Series of Randomized Controlled Experiments during a Large COVID-19 Study JO - JMIR Public Health Surveill SP - e60022 VL - 11 KW - study recruitment KW - response rate KW - population-based research KW - COVID-19 KW - SARS-CoV-2 KW - web-based questionnaires N2 - Background: High response rates are needed in population-based studies, as nonresponse reduces effective sample size and bias affects accuracy and decreases the generalizability of the study findings. Objective: We tested different strategies to improve response rate and reduce nonresponse bias in a national population?based COVID-19 surveillance program in England, United Kingdom. Methods: Over 19 rounds, a random sample of individuals aged 5 years and older from the general population in England were invited by mail to complete a web-based questionnaire and return a swab for SARS-CoV-2 testing. We carried out several nested randomized controlled experiments to measure the impact on response rates of different interventions, including (1) variations in invitation and reminder letters and SMS text messages and (2) the offer of a conditional monetary incentive to return a swab, reporting absolute changes in response and relative response rate (95% CIs). Results: Monetary incentives increased the response rate (completed swabs returned as a proportion of the number of individuals invited) across all age groups, sex at birth, and area deprivation with the biggest increase among the lowest responders, namely teenagers and young adults and those living in more deprived areas. With no monetary incentive, the response rate was 3.4% in participants aged 18?22 years, increasing to 8.1% with a £10 (US $12.5) incentive, 11.9% with £20 (US $25.0), and 18.2% with £30 (US $37.5) (relative response rate 2.4 [95% CI 2.0-2.9], 3.5 [95% CI 3.0-4.2], and 5.4 [95% CI 4.4-6.7], respectively). Nonmonetary strategies had a modest, if any, impact on response rate. The largest effect was observed for sending an additional swab reminder (SMS text message or email). For example, those receiving an additional SMS text message were more likely to return a completed swab compared to those receiving the standard email-SMS approach, 73.3% versus 70.2%: percentage difference 3.1% (95% CI 2.2%-4.0%). Conclusions: Conditional monetary incentives improved response rates to a web-based survey, which required the return of a swab test, particularly for younger age groups. Used in a selective way, incentives may be an effective strategy for improving sample response and representativeness in population-based studies. UR - https://publichealth.jmir.org/2025/1/e60022 UR - http://dx.doi.org/10.2196/60022 ID - info:doi/10.2196/60022 ER - TY - JOUR AU - Denny, Alanna AU - Ndemera, Isaach AU - Chirwa, Kingston AU - Wu, Shu Joseph Tsung AU - Chirambo, Baxter Griphin AU - Yosefe, Simeon AU - Chilima, Ben AU - Kagoli, Matthew AU - Lee, Hsin-yi AU - Yu, Joseph Kwong Leung AU - O'Donoghue, John PY - 2024/12/31 TI - Evaluation of the Development, Implementation, Maintenance, and Impact of 3 Digital Surveillance Tools Deployed in Malawi During the COVID-19 Pandemic: Protocol for a Modified Delphi Expert Consensus Study JO - JMIR Res Protoc SP - e58389 VL - 13 KW - delphi study KW - COVID-19 KW - Malawi KW - surveillance KW - digital health KW - delphi KW - mobile health KW - mHealth KW - development KW - implementation KW - maintenance KW - impact KW - consensus KW - protocol KW - survey KW - expert KW - purposive sampling KW - epidemiology KW - descriptive statistics N2 - Background: The COVID-19 pandemic has highlighted the importance of strengthening national monitoring systems to safeguard a globally connected society, especially those in low- and middle-income countries. Africa?s rapid adoption of digital technological interventions created a new frontier of digital advancement during crises or pandemics. The use of digital tools for disease surveillance can assist with rapid outbreak identification and response, handling duties such as diagnosis, testing, contact tracing, and risk communication. Malawi was one of the first countries in the region to launch a government-led coordinated effort to harmonize and streamline the necessary COVID-19 digital health implementation through an integrated system architecture. Objective: The aim of this study is to seek expert consensus using the Delphi methodology to examine Malawi?s COVID-19 digital surveillance response strategy and to assess the digital tools using the World Health Organization mHealth (mobile health) Assessment and Planning for Scale (MAPS) toolkit. Methods: This protocol follows the Guidance on Conducting and REporting DElphi Studies. Participants must have first-hand experience on the design, implementation or maintenance with COVID-19 digital surveillance systems. There will be no restrictions on the level of expertise or years of experience. The panel will consist of approximately 40 participants. We will use a modified Delphi process whereby rounds 1 and 2 will be hosted online by Qualtrics and round 3 will encompass a face-to-face workshop held in Malawi. Consensus will be defined as ?70% of participants strongly disagree, disagree, or somewhat disagree, or strongly agree, agree, or somewhat agree. During round 3, the face-to-face workshop, participants will be asked to complete, the MAPS toolkit assessment on the digital tool on which they are experts. The MAPS toolkit will enable the panel members to assess the digital tools from a sustainable perspective from six distinct, yet complementary axes: (1) groundwork, (2) partnerships, (3) financial health, (4) technology and architecture, (5) operations, and (6) monitoring and evaluation. Results: The ability of a country to collate, diagnose, monitor, and analyze data forms the cornerstone of an efficient surveillance system, allowing countries to plan and implement appropriate control actions. Malawi was one of the first countries in the African region to launch a government-led coordinated effort to harmonize and streamline the necessary COVID-19 digital health implementation through an integrated system architecture. Conclusions: We anticipate findings from this Delphi study will provide insights into how and why Malawi was successful in deploying digital surveillance systems. In addition, findings should produce recommendations and guidance for the rapid development, implementation, maintenance, and impact of digital surveillance tools during a health crisis. International Registered Report Identifier (IRRID): DERR1-10.2196/58389 UR - https://www.researchprotocols.org/2024/1/e58389 UR - http://dx.doi.org/10.2196/58389 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/58389 ER - TY - JOUR AU - Meyer, Lene AU - Køster-Rasmussen, Rasmus AU - Christiansen, Lindahl Ann-Kathrin AU - Heitmann, Lilienthal Berit AU - Vesterlund, Kingo Gitte AU - Larsen, Christian Sofus AU - Specht, Olmer Ina AU - Thorsteinsdottir, Fanney AU - Steinbo, Frøhlke Emma Katrine AU - Appel, Lundmark Clara AU - Sigurdardottir, Agusta Gudrun AU - Reventlow, Susanne AU - Waldorff, Boch Frans AU - Sandholdt, Thiel Catharina PY - 2024/11/29 TI - Developing a Weight-Neutral Health Intervention in Denmark: Protocol for a Co-Design Process JO - JMIR Public Health Surveill SP - e59455 VL - 10 KW - obesity KW - weight management KW - complex intervention KW - patient engagement KW - health intervention KW - Denmark KW - Danish KW - lifestyle KW - weight loss KW - weight reduction KW - stigma KW - neutral health KW - human-centered design KW - dissemination KW - podcast KW - social media KW - feasibility study KW - public health KW - surveillance N2 - Background: Lifestyle interventions for weight loss are generally ineffective in achieving clinically meaningful long-term reductions in body weight and may contribute to negative behavior such as weight cycling or disordered eating. Negative focus on high weight may also contribute to weight stigma. Weight stigma includes negative attitudes and discriminatory behavior toward people with big bodies and can result in psychological stress and unfavorable health outcomes. Taken together, it is possible that the potential harms of lifestyle-based weight loss interventions may exceed the potential benefits. Weight-neutral health (WNH) has emerged as an alternative strategy advocating for size diversity, intuitive eating, and joyful physical movement, all without placing emphasis on weight reduction. Objective: This protocol outlines the study design for the co-design process of developing a WNH complex intervention, engaging relevant stakeholders in Denmark. Methods: We base our understanding of WNH on the principles from Health at Every Size: body acceptance, joyful movement, intuitive eating, and weight stigma reduction. The co-design development process is based on the Medical Research Council?s framework for complex interventions and applies methods from human-centered design through 4 iterative design phases of engaging stakeholders?discover: search existing literature, and conduct interviews with Danish municipal stakeholders working with WNH and other expert stakeholders; define: coproduction of seminars with health professionals (HPs) with knowledge of WNH, and semistructured interviews with people with BMI?30 kg/m2 who have participated in existing WNH interventions; design: content-creating workshops with HPs and people with BMI?30 kg/m2; and validate: evaluate seminars, plan feasibility, and produce materials. The data will be analyzed thematically to build a scaffold for the intervention activities and components. In further analysis, we will explore how health is performed, meaning the actions and dialogues that arise when dealing with health guidelines, the societal body, weight, and health expectations, in the context of the intervention. Results: The project is fully funded. As of August 2024, the co-design process was in the closing phase. In total, 15 HPs were included, some of whom have larger body sizes. This provides a dual perspective, combining their personal experiences of living with a high BMI with their professional expertise. In total, 16 people with BMI?30 kg/m2 have generously shared their experiences with WNH programs, including the difficulties of moving away from external demands and personal wishes for weight loss. Their contributions have nuanced and unfolded our understanding of the principles of WNH in a Danish setting. Conclusions: The intervention designed in and from the co-design process will be tested for feasibility in 2025. The findings from the feasibility study will inform a future randomized controlled trial and present novel findings in the field of health management. The long-term goal is to implement the intervention in a Danish municipal setting free of charge. UR - https://publichealth.jmir.org/2024/1/e59455 UR - http://dx.doi.org/10.2196/59455 ID - info:doi/10.2196/59455 ER - TY - JOUR AU - Brugger, Curdin AU - Dietler, Dominik AU - Abu Hamad, A. Bassam AU - van Gastel, Tammo AU - Sittaro, Federico AU - Rossi, Rodolfo AU - Owen, Nia Branwen AU - Probst-Hensch, Nicole AU - Winkler, S. Mirko PY - 2024/11/29 TI - Assessment of Health and Well-Being Effects Associated With the Challenging Drinking Water Situation in the Gaza Strip: Protocol for a Cross-Sectional Household Survey Study JO - JMIR Res Protoc SP - e63415 VL - 13 KW - drinking water KW - water quality KW - households survey KW - noncommunicable diseases KW - protracted conflict KW - humanitarian crisis KW - Gaza Strip KW - well-being N2 - Background: The water supply in the Gaza Strip, Palestine, has been unstable and under strain for decades, resulting in major issues with drinking water quality, reliability, and acceptability. In 2018, between 25% and 30% of Gazans did not have regular access to running water. The progressive deterioration of water infrastructure and concerns over the quality of piped water have resulted in a complex mix of drinking water sources used in the Gaza Strip. The challenges of safe water provision in the Gaza Strip could potentially have severe adverse effects on the population?s health and well-being. Objective: The main objectives of this survey are to determine the quality of drinking water at the household level and to investigate the association of various health outcomes with water quality at the household level in the Gaza Strip. Methods: We conducted a cross-sectional household survey in the North Gaza, Gaza, and Rafah governorates between January and March 2023. We selected a subsample of households from a representative cross-sectional survey conducted in the Gaza Strip in 2020 with persons aged 40 years and older. From each household in the 2023 survey, we invited 3 individuals (2 older than 40 years and 1 between 18 and 30 years) to participate. The face-to-face interview included questions on drinking water, mental health and well-being, self-reported diagnoses for selected diseases, use of antibiotics, and knowledge about antimicrobial resistance. Additionally, we measured each participant?s blood pressure. We sampled drinking water from each household and analyzed the samples for microbial contamination, nitrate, sodium, and mineral content. Results: In total, we visited 905 households and interviewed 2291 participants. In both age groups, more female participants were interviewed. A total of 56.60% (914/1615) were aged ?40 years, and 58.9% (398/676) were aged between 18 and 30 years. We obtained water samples from nearly all households (902/905, 99.8%). The results are expected to be published in several papers in 2025. Conclusions: The extensive survey components, coupled with drinking water testing and building on an existing survey, allowed us to identify a broad set of potential impacts on health and well-being and to track changes over time. This study intends to identify humanitarian and development interventions that could impact the population served most. However, we completed data collection before the escalation of violence in October 2023. Given the impact of the still ongoing conflict, the initial intent of this work is no longer valid. However, the results emerging from the survey may still serve as a valuable baseline to assess the impacts of the current escalations on physical and mental health and on drinking water quality. In addition, our findings could provide important information for rebuilding the Gaza Strip in a more health-promoting way. International Registered Report Identifier (IRRID): DERR1-10.2196/63415 UR - https://www.researchprotocols.org/2024/1/e63415 UR - http://dx.doi.org/10.2196/63415 UR - http://www.ncbi.nlm.nih.gov/pubmed/39612204 ID - info:doi/10.2196/63415 ER - TY - JOUR AU - Mengistu, Meron AU - Tom, Kris AU - Gebremikael, Liben AU - Massaquoi, Notisha AU - Ezezika, Obidimma PY - 2024/11/29 TI - Tracking Implementation Outcomes of an Intensive Case Management Program for HIV: Protocol for a Mixed Methods Study JO - JMIR Res Protoc SP - e57452 VL - 13 KW - implementation science KW - intensive case management KW - ICM KW - human immunodeficiency virus KW - HIV KW - tracking KW - outcome KW - fidelity KW - reach KW - sustainability KW - implementation outcomes KW - perspective KW - perception KW - Toronto KW - Canada KW - descriptive statistics KW - evidence-based intervention KW - effectiveness KW - barriers KW - facilitators KW - adoption N2 - Background: Implementation science investigates the processes and factors that influence the successful adoption, implementation, and sustainability of interventions in many settings. Although conventional research places significant emphasis on the advancement and effectiveness of interventions, it is equally imperative to comprehend their performance in practical, real-life situations. Through outcome tracking, implementation science enables researchers to investigate complex implementation dynamics and go beyond efficacy, identifying the various aspects that contribute to the success of interventions. Objective: This study aims to evaluate the implementation outcomes of TAIBU?s intensive case management (ICM) model tailored for African, Caribbean, and Black communities living with HIV in the Greater Toronto Area. Specifically, it seeks to assess the fidelity, reach, and sustainability of the ICM program. Fidelity monitoring will ensure adherence to program protocols and consistency in service delivery, essential for achieving desired health outcomes. Reach assessment will examine the program?s capacity to reach the target population, including demographic coverage and engagement levels among African, Caribbean, and Black individuals. Sustainability assessment will explore the determinants influencing the longevity and impact of the ICM program. Methods: The study uses a mixed methods approach, where we will use probing questionnaires, interviews, and focus-group discussions to gather program performance and engagement data, in-depth insights, and perspectives from the implementation team responsible for delivering the ICM intervention. The collected fidelity and reach data through questionnaires will be analyzed using appropriate statistical techniques, such as descriptive statistics, to summarize the responses and identify patterns and trends within the data. Sustainability data collected through the interviews and focus groups will be analyzed and organized based on the Consolidated Framework for Implementation Research, which provides an organized way to identify and comprehend the determinants influencing implementation outcomes. Results: The study commenced in January 2024, and initial data collection is expected to be completed by December 2024. As of September 2024, we have enrolled 5 participants. Conclusions: This study will significantly contribute to improving the implementation of the ICM program. By conducting a study in an organizational or institutional setting, researchers can acquire valuable insights into the implementation process from those who are directly involved. The information gathered will inform strategies for improving implementation effectiveness; removing impediments; and enhancing the overall quality of the ICM program for African, Caribbean, and Black individuals living with HIV. International Registered Report Identifier (IRRID): DERR1-10.2196/57452 UR - https://www.researchprotocols.org/2024/1/e57452 UR - http://dx.doi.org/10.2196/57452 UR - http://www.ncbi.nlm.nih.gov/pubmed/39612213 ID - info:doi/10.2196/57452 ER - TY - JOUR AU - Jefferson, Emily AU - Milligan, Gordon AU - Johnston, Jenny AU - Mumtaz, Shahzad AU - Cole, Christian AU - Best, Joseph AU - Giles, Charles Thomas AU - Cox, Samuel AU - Masood, Erum AU - Horban, Scott AU - Urwin, Esmond AU - Beggs, Jillian AU - Chuter, Antony AU - Reilly, Gerry AU - Morris, Andrew AU - Seymour, David AU - Hopkins, Susan AU - Sheikh, Aziz AU - Quinlan, Philip PY - 2024/11/20 TI - The Challenges and Lessons Learned Building a New UK Infrastructure for Finding and Accessing Population-Wide COVID-19 Data for Research and Public Health Analysis: The CO-CONNECT Project JO - J Med Internet Res SP - e50235 VL - 26 KW - COVID-19 KW - infrastructure KW - trusted research environments KW - safe havens KW - feasibility analysis KW - cohort discovery KW - federated analytics KW - federated discovery KW - lessons learned KW - population wide KW - data KW - public health KW - analysis KW - CO-CONNECT KW - challenges KW - data transformation UR - https://www.jmir.org/2024/1/e50235 UR - http://dx.doi.org/10.2196/50235 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/50235 ER - TY - JOUR AU - Bermejo-Martínez, Gemma AU - Julián, Antonio José AU - Villanueva-Blasco, José Víctor AU - Aibar, Alberto AU - Corral-Abós, Ana AU - Abarca-Sos, Alberto AU - Generelo, Eduardo AU - Mur, Melania AU - Bueno, Manuel AU - Ferrer, Elisa AU - Artero, Isabel AU - García-González, Luis AU - Murillo-Pardo, Berta AU - Ferriz, Roberto AU - Menal-Puey, Susana AU - Marques-Lopes, Iva AU - Fajó-Pascual, Marta AU - Ibor-Bernalte, Eduardo AU - Zaragoza Casterad, Javier PY - 2024/11/20 TI - Development of a Web Platform to Facilitate the Implementation and Evaluation of Health Promoting Schools: Protocol for a Double Diamond Design Approach JO - JMIR Res Protoc SP - e52110 VL - 13 KW - web platform KW - health promoting schools KW - co-design process KW - Double Diamond Design Model KW - implementation processes. N2 - Background: Health Promoting Schools (HPS) have emerged as a powerful framework to promote healthy behaviors in many countries. However, HPS still present several challenges, highlighting the excessive workload involved in the accreditation, design, implementation, and evaluation processes. In this sense, a resource to facilitate the implementation processes may have a positive impact on the support of HPS. Objective: The aim of this study was to describe the co-design processes undertaken and resulting learnings to develop the Red Escuelas Promotoras de Salud (network of health promoting schools; REDEPS)-Gestion platform to facilitate the accreditation, design, implementation procedures, and evaluation processes of the Aragon's Health-Promoting School Network. Methods: The Double Diamond Design Approach was used to co-design this web-platform. The different stakeholders that participated in this co-design, progressed through a 4-stage reflective phase, to discover, define, develop, and deliver the REDEPS-Gestion platform. Results: Participants agreed that the functions of the REDEPS-Gestion platform should permit the management of both the educational centers and the administration such as accreditation processes, definition and review intervention projects, and preparation and review of the different progress reports to evaluate the HPS. Despite co-design being a well-established approach to creative practice, especially within the public sector, some challenges emerged during the co-design process, such as engaging and facilitating stakeholders? participation or the complexity of combining the interests of all stakeholders. This approach allowed us to identify the main barriers for future users and implement platform improvements. Conclusions: We hope that the REDEPS-Gestion platform will therefore be able to contribute to facilitating the implementation of HPS. The Double Diamond Design Approach used to co-design this web platform was an efficient and feasible methodological design approach. The REDEPS-Gestion platform will facilitate HPS implementation in Aragon as well as all the processes involving HPS. Future work will determine its effectiveness in improving HPS implementation. International Registered Report Identifier (IRRID): DERR1-10.2196/52110 UR - https://www.researchprotocols.org/2024/1/e52110 UR - http://dx.doi.org/10.2196/52110 UR - http://www.ncbi.nlm.nih.gov/pubmed/39566054 ID - info:doi/10.2196/52110 ER - TY - JOUR AU - Correia, Façanha Rafaela Bezerra AU - Mourad, Prudlik Rafaela AU - Dantas, Costa Janmilli da AU - Silva, da Richardson Augusto Rosendo PY - 2024/11/15 TI - Barriers and Facilitators Affecting Access to Health Care for People With Syphilis: Protocol for a Scoping Review JO - JMIR Res Protoc SP - e63561 VL - 13 KW - syphilis KW - acquired syphilis KW - congenital syphilis KW - gestational syphilis KW - Treponema pallidum KW - health services accessibility KW - access to health services KW - scoping review N2 - Background: Syphilis is a systemic, preventable, and curable infection caused by the bacterium Treponema pallidum. Despite being treatable, syphilis continues to have a high incidence, with a resurgence observed even in countries with strong health surveillance systems. This highlights the need to understand the various strategies used globally to improve access to care for individuals with syphilis. Objective: This scoping review aims to identify and map the barriers and facilitators affecting access to health care for people with syphilis. Methods: This scoping review will follow the methodology outlined by the Joanna Briggs Institute. The search will be conducted across several databases, including PubMed/MEDLINE, Scopus, Embase, LILACS (Virtual Health Library), and CINAHL (EBSCO). In addition, sources of unpublished studies or gray literature will be explored. Studies focusing on access to health care for individuals with syphilis will be included, regardless of geographic location, country, or language. Two independent reviewers will assess the results, and data will be extracted using a tool specifically developed for this review. The extracted quantitative data will be presented in tables and analyzed using descending hierarchical classification, represented by a class dendrogram. Barriers and facilitators will be categorized into dimensions of access. Results: Database searching began in October 2024. Full-text screening and review are expected to be completed in December 2024. Data extraction and analysis are expected to be completed by February 2025, and the final report will be completed in March 2025. Conclusions: The findings of this scoping review, guided by this protocol, will elucidate the main barriers and facilitators that affect access to syphilis treatment. This study may contribute to the practices of health professionals, managers, and the academic community, and provide relevant information for the population. Trial Registration: Open Science Framework Registries osf.io/kpsab; https://osf.io/kpsab International Registered Report Identifier (IRRID): PRR1-10.2196/63561 UR - https://www.researchprotocols.org/2024/1/e63561 UR - http://dx.doi.org/10.2196/63561 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/63561 ER - TY - JOUR AU - Hope, Mackline AU - Kiggundu, Reuben AU - Byonanebye, M. Dathan AU - Mayito, Jonathan AU - Tabajjwa, Dickson AU - Lwigale, Fahad AU - Tumwine, Conrad AU - Mwanja, Herman AU - Kambugu, Andrew AU - Kakooza, Francis PY - 2024/11/15 TI - Progress of Implementation of World Health Organization Global Antimicrobial Resistance Surveillance System Recommendations on Priority Pathogen-Antibiotic Sensitivity Testing in Africa: Protocol for a Scoping Review JO - JMIR Res Protoc SP - e58140 VL - 13 KW - antimicrobial resistance KW - antibiotic sensitivity testing KW - global antimicrobial resistance surveillance system KW - GLASS implementation KW - AMR Surveillance KW - Africa N2 - Background: Antimicrobial resistance (AMR) is a major global public health concern, particularly in low- and middle-income countries where resources and infrastructure for an adequate response are limited. The World Health Organization (WHO) Global Antimicrobial Resistance Surveillance System (GLASS) was introduced in 2016 to address these challenges, outlining recommendations for priority pathogen-antibiotic combinations. Despite this initiative, implementation in Africa remains understudied. This scoping review aims to assess the current state of implementing WHO GLASS recommendations on antimicrobial sensitivity testing (AST) in Africa. Objective: The primary objective of this study is to determine the current state of implementing the WHO GLASS recommendations on AST for priority pathogen-antimicrobial combinations. The review will further document if the reporting of AST results is according to ?susceptible,? ?intermediate,? and ?resistant? recommendations according to GLASS. Methods: Following the methodological framework by Arksey and O?Malley, studies published between January 2016 and November 2023 will be included. Search strategies will target electronic databases, including MEDLINE, Scopus, CINAHL, and Embase. Eligible studies will document isolates tested for antimicrobial sensitivity, focusing on WHO-priority specimens and pathogens. Data extraction will focus on key study characteristics, study context, population, and adherence to WHO GLASS recommendations on AST. Descriptive statistics involving summarizing the quantitative data extracted through measures of central tendency and variation will be used. Covidence and Microsoft Excel software will be used. This study will systematically identify, collate, and analyze relevant studies and data sources based on clear inclusion criteria to provide a clear picture of the progress achieved in the implementation of the WHO GLASS recommendations. Areas for further improvement will be documented to inform future efforts to strengthen GLASS implementation for enhanced AMR surveillance in Africa. Results: The study results are expected in August 2024. Conclusions: To our knowledge, this scoping review will be the first to comprehensively examine the implementation of WHO GLASS recommendations in Africa, shedding light on the challenges and successes of AMR surveillance in the region. Addressing these issues aims to contribute to global efforts to combat AMR. International Registered Report Identifier (IRRID): PRR1-10.2196/58140 UR - https://www.researchprotocols.org/2024/1/e58140 UR - http://dx.doi.org/10.2196/58140 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/58140 ER - TY - JOUR AU - Tieu, Van Hong AU - Nandi, Vijay AU - Diaz, E. José AU - Greene, Emily AU - Walcott, Melonie AU - Curriero, Frank AU - Desjardins, R. Michael AU - Wychgram, Cara AU - Latkin, Carl AU - Rundle, G. Andrew AU - Frye, A. Victoria AU - PY - 2024/11/13 TI - Neighborhoods, Networks, and HIV Care Among Men Who Have Sex With Men: Proposal for a Longitudinal Study JO - JMIR Res Protoc SP - e64358 VL - 13 KW - neighborhoods KW - social networks KW - HIV care outcomes KW - men who have sex with men KW - living with HIV KW - activity spaces N2 - Background: The majority of people living with HIV in the United States are men who have sex with men (MSM), with race- and ethnicity-based disparities in HIV rates and care continuum. In order to uncover the neighborhood- and network-involved pathways that produce HIV care outcome disparities, systematic, theory-based investigation of the specific and intersecting neighborhood and social network characteristics that relate to the HIV care continuum must be engaged. Objective: Using socioecological and intersectional conceptual frameworks, we aim to identify individual-, neighborhood-, and network-level characteristics associated with HIV care continuum outcomes (viral suppression, retention in care, and antiretroviral adherence) among MSM living with HIV in New York City. Methods: In the longitudinal cohort study, we assess 3 neighborhoods of potential influence (residential, social, and health care access activity spaces) using Google Earth. We investigate the influence of neighborhood composition (eg, concentrated poverty and racial segregation) and four neighborhood-level characteristics domains: (1) community violence, physical disorder, and social disorganization (eg, crime rates and housing vacancy); (2) alcohol and other drug use; (3) social norms (eg, homophobia and HIV stigma); and (4) community resources (eg, social services and public transit access). We test theoretical pathways of influence, including stress or coping, stigma or resilience, and access to resources, across the different neighborhoods in which MSM live, socialize, and receive HIV care. At each visit, we locate each participant?s reported activity spaces (ie, neighborhoods of potential influence) and collect individual-level data on relevant covariates (including perceptions of or exposure to neighborhoods) and social network inventory data on the composition, social support, and perceived social norms. The outcomes are HIV viral suppression, retention in care, and antiretroviral adherence. These data are combined with an existing, extensive geospatial database of relevant area characteristics. Spatial analysis and multilevel modeling are used to test the main theory-driven hypotheses and capture independent neighborhood-level and network-level effects and changes over time. Results: The study began enrollment in March 2019 and concluded visits in December 2023, with a total of 327 participants enrolled. The median age was 44.1 (SD 11.5) years. Almost all participants self-identified as cisgender men (n=313, 98.1%) and as gay, homosexual, or bisexual (n=301, 94.4%). Overall, 192 (60.1%) participants identified as non-Hispanic Black, and 81 (25.3%) identified as Hispanic. Most (n=201, 63%) reported at least occasional difficulty in meeting basic needs (eg, rent and food) in the past 6 months. The mean number of years living with HIV was 15.4 (SD 10.1). Conclusions: This study will have direct implications for the design of multilevel interventions, addressing factors at the neighborhood, network, and individual levels. Results may inform urban planning and program design to improve HIV care outcomes for MSM, particularly for Black and Latino MSM living in urban areas. International Registered Report Identifier (IRRID): PRR1-10.2196/64358 UR - https://www.researchprotocols.org/2024/1/e64358 UR - http://dx.doi.org/10.2196/64358 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/64358 ER - TY - JOUR AU - Mayito, Jonathan AU - Tumwine, Conrad AU - Galiwango, Ronald AU - Nuwamanya, Elly AU - Nakasendwa, Suzan AU - Hope, Mackline AU - Kiggundu, Reuben AU - Byonanebye, M. Dathan AU - Dhikusooka, Flavia AU - Twemanye, Vivian AU - Kambugu, Andrew AU - Kakooza, Francis PY - 2024/11/8 TI - Combating Antimicrobial Resistance Through a Data-Driven Approach to Optimize Antibiotic Use and Improve Patient Outcomes: Protocol for a Mixed Methods Study JO - JMIR Res Protoc SP - e58116 VL - 13 KW - antimicrobial resistance KW - AMR database KW - AMR KW - machine learning KW - antimicrobial use KW - artificial intelligence KW - antimicrobial KW - data-driven KW - mixed-method KW - patient outcome KW - drug-resistant infections KW - drug resistant KW - surveillance data KW - economic KW - antibiotic N2 - Background: It is projected that drug-resistant infections will lead to 10 million deaths annually by 2050 if left unabated. Despite this threat, surveillance data from resource-limited settings are scarce and often lack antimicrobial resistance (AMR)?related clinical outcomes and economic burden. We aim to build an AMR and antimicrobial use (AMU) data warehouse, describe the trends of resistance and antibiotic use, determine the economic burden of AMR in Uganda, and develop a machine learning algorithm to predict AMR-related clinical outcomes. Objective: The overall objective of the study is to use data-driven approaches to optimize antibiotic use and combat antimicrobial-resistant infections in Uganda. We aim to (1) build a dynamic AMR and antimicrobial use and consumption (AMUC) data warehouse to support research in AMR and AMUC to inform AMR-related interventions and public health policy, (2) evaluate the trends in AMR and antibiotic use based on annual antibiotic and point prevalence survey data collected at 9 regional referral hospitals over a 5-year period, (3) develop a machine learning model to predict the clinical outcomes of patients with bacterial infectious syndromes due to drug-resistant pathogens, and (4) estimate the annual economic burden of AMR in Uganda using the cost-of-illness approach. Methods: We will conduct a study involving data curation, machine learning?based modeling, and cost-of-illness analysis using AMR and AMU data abstracted from procurement, human resources, and clinical records of patients with bacterial infectious syndromes at 9 regional referral hospitals in Uganda collected between 2018 and 2026. We will use data curation procedures, FLAIR (Findable, Linkable, Accessible, Interactable and Repeatable) principles, and role-based access control to build a robust and dynamic AMR and AMU data warehouse. We will also apply machine learning algorithms to model AMR-related clinical outcomes, advanced statistical analysis to study AMR and AMU trends, and cost-of-illness analysis to determine the AMR-related economic burden. Results: The study received funding from the Wellcome Trust through the Centers for Antimicrobial Optimisation Network (CAMO-Net) in April 2023. As of October 28, 2024, we completed data warehouse development, which is now under testing; completed data curation of the historical Fleming Fund surveillance data (2020-2023); and collected retrospective AMR records for 599 patients that contained clinical outcomes and cost-of-illness economic burden data across 9 surveillance sites for objectives 3 and 4, respectively. Conclusions: The data warehouse will promote access to rich and interlinked AMR and AMU data sets to answer AMR program and research questions using a wide evidence base. The AMR-related clinical outcomes model and cost data will facilitate improvement in the clinical management of AMR patients and guide resource allocation to support AMR surveillance and interventions. International Registered Report Identifier (IRRID): PRR1-10.2196/58116 UR - https://www.researchprotocols.org/2024/1/e58116 UR - http://dx.doi.org/10.2196/58116 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/58116 ER - TY - JOUR AU - Durkin, M. Amanda AU - Zou, Runyu AU - Boucher, M. Justin AU - Boyles, SP Matthew AU - van Boxel, Jeske AU - Bustamante, Mariona AU - Christopher, A. Emily AU - Dadvand, Payam AU - Dusza, M. Hanna AU - van Duursen, Majorie AU - Forsberg, M. Markus AU - Galea, S. Karen AU - Legler, Juliette AU - Mandemaker, DB Laurens AU - Meirer, Florian AU - Muncke, Jane AU - Nawrot, S. Tim AU - P?ibylová, Petra AU - Robuck, R. Anna AU - Saenen, D. Nelly AU - Scholz-Böttcher, M. Barbara AU - Shao, Kuanliang AU - Vrijheid, Martine AU - Walker, I. Douglas AU - Zimmermann, Lisa AU - Zoutendijk, M. Laura AU - Lenters, Virissa AU - Vermeulen, Roel PY - 2024/10/8 TI - Investigating Exposure and Hazards of Micro- and Nanoplastics During Pregnancy and Early Life (AURORA Project): Protocol for an Interdisciplinary Study JO - JMIR Res Protoc SP - e63176 VL - 13 KW - epidemiology KW - pregnancy KW - toxicology KW - microplastics KW - placenta KW - risk assessment N2 - Background: Micro- and nanoplastics (MNPs) are emerging pollutants of concern with ubiquitous presence in global ecosystems. MNPs pose potential implications for human health; however, the health impacts of MNP exposures are not yet understood. Recent evidence suggests that MNPs can cross the placental barrier, underlying the urgent need to understand their impact on reproductive health and development. Objective: The Actionable eUropean ROadmap for early-life health Risk Assessment of micro- and nanoplastics (AURORA) project will investigate MNP exposures and their biological and health effects during pregnancy and early life, which are critical periods due to heightened vulnerability to environmental stressors. The AURORA project will enhance exposure assessment capabilities for measuring MNPs, MNP-associated chemicals, and plastic additives in human tissues, including placenta and blood. Methods: In this interdisciplinary project, we will advance methods for in-depth characterization and scalable chemical analytical strategies, enabling high-resolution and large-scale toxicological, exposure assessment, and epidemiological studies. The AURORA project performs observational studies to investigate determinants and health impacts of MNPs by including 800 mother-child pairs from 2 existing birth cohorts and 110 women of reproductive age from a newly established cohort. This will be complemented by toxicological studies using a tiered-testing approach and epidemiological investigations to evaluate associations between maternal and prenatal MNP exposures and health perturbations, such as placental function, immune-inflammatory responses, oxidative stress, accelerated aging, endocrine disruption, and child growth and development. The ultimate goal of the AURORA project is to create an MNP risk assessment framework and identify the remaining knowledge gaps and priorities needed to comprehensively assess the impact of MNPs on early-life health. Results: In the first 3 years of this 5-year project (2021-2026), progress was made toward all objectives. This includes completion of recruitment and data collection for new and existing cohorts, development of analytical methodological protocols, and initiation of the toxicological tiered assessments. As of September 2024, data analysis is ongoing and results are expected to be published starting in 2025. Conclusions: As plastic pollution increases globally, it is imperative to understand the impact of MNPs on human health, particularly during vulnerable developmental stages such as early life. The contributions of the AURORA project will inform future risk assessment. International Registered Report Identifier (IRRID): DERR1-10.2196/63176 UR - https://www.researchprotocols.org/2024/1/e63176 UR - http://dx.doi.org/10.2196/63176 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/63176 ER - TY - JOUR AU - Motreff, Yvon AU - Marillier, Maude AU - Saoudi, Abdessattar AU - Verdot, Charlotte AU - Seconda, Louise AU - Pognon, Damien AU - Khireddine-Medouni, Imane AU - Richard, Jean-Baptiste AU - Kovess-Masfety, Viviane AU - Delorme, Richard AU - Decio, Valentina AU - Perrine, Anne-Laure AU - El Haddad, Maria AU - Gallay, Anne AU - Monnier-Besnard, Stéphanie AU - Regnault, Nolwenn AU - PY - 2024/8/13 TI - Implementation of a Novel Epidemiological Surveillance System for Children?s Mental Health and Well-Being in France: Protocol for the National ?Enabee? Cross-Sectional Study JO - JMIR Public Health Surveill SP - e57584 VL - 10 KW - child KW - mental health KW - epidemiological surveillance KW - well-being N2 - Background: Children?s mental health, including their well-being, is a major public health concern, as the burden of related disorders may last throughout one?s life. Although epidemiological mental health surveillance systems for children and adolescents have been implemented in several countries, they are sorely lacking in France. Objective: This study aims to describe the first step of the implementation of a novel surveillance system in France called Enabee (Etude nationale sur le bien-être des enfants), which focuses on the issue of mental health in children. The system aims to (1) describe the temporal trends in the population-based prevalence of the main mental health disorders and well-being in children aged 3 to 11 years, (2) explore their major determinants, and (3) assess mental health care use by this population. To do this, Enabee will rely on results from a recurrent national cross-sectional homonymous study. This paper presents the protocol for the first edition of this study (called Enabee 2022), as well as initial results regarding participation. Methods: Enabee 2022 is a national cross-sectional study that was implemented in French schools in 2022. It used a probabilistic, multistage, stratified, and balanced sampling plan as follows: first, schools were randomly drawn and stratified according to the type of school. Up to 4 classes per school were then randomly drawn, and finally, all the pupils within each class were selected. The study covered children from preschool and kindergarten (aged 3 to 6 years, US grading system) to fifth grade (aged 6 to 11 years). Children from first to fifth grades provided a self-assessment of their mental health using 2 validated self-administered questionnaires: the Dominic Interactive (DI) and the KINDL. Parents and teachers completed a web-based questionnaire, including the Strengths and Difficulties Questionnaire. Parents also answered additional questions about their parenting attitudes; their own mental health; known social, economic, and environmental determinants of mental health in children; and their child?s life habits. Health, education, and family stakeholders were involved in designing and implementing the study as part of a large consultation group. Results: Data were collected from May 2, 2022, to July 31, 2022, in 399 schools across metropolitan France. Teachers completed questionnaires for 5721 pupils in preschool and kindergarten and for 15,263 pupils from first to fifth grades. Parents completed questionnaires for 3785 children in preschool and kindergarten and for 9227 children from first to fifth grades. Finally, 15,206 children from first to fifth grades completed the self-administered questionnaire. Conclusions: Enabee 2022 constitutes the first milestone in the development of a novel national epidemiological surveillance system, paving the way for improved children?s mental health policies in France. UR - https://publichealth.jmir.org/2024/1/e57584 UR - http://dx.doi.org/10.2196/57584 UR - http://www.ncbi.nlm.nih.gov/pubmed/39137010 ID - info:doi/10.2196/57584 ER - TY - JOUR AU - Bhattacharjee, Parinita AU - McClarty, M. Leigh AU - Kimani, Joshua AU - Isac, Shajy AU - Wanjiru Kabuti, Rhoda AU - Kinyua, Antony AU - Karakaja Okoyana, Jaffred AU - Njeri Ndukuyu, Virjinia AU - Musyoki, Helgar AU - Kiplagat, Anthony AU - Arimi, Peter AU - Shaw, Souradet AU - Emmanuel, Faran AU - Gandhi, Monica AU - Becker, Marissa AU - Blanchard, James PY - 2024/6/19 TI - Assessing Outcomes in HIV Prevention and Treatment Programs With Female Sex Workers and Men Who Have Sex With Men: Expanded Polling Booth Survey Protocol JO - JMIR Public Health Surveill SP - e54313 VL - 10 KW - female sex workers KW - men who have sex with men KW - Kenya KW - polling booth survey KW - program science KW - HIV prevention KW - outcome assessment N2 - Background: Assessing HIV outcomes in key population prevention programs is a crucial component of the program cycle, as it facilitates improved planning and monitoring of anticipated results. The Joint United Nations Programme on HIV and AIDS recommends using simple, rapid methods to routinely measure granular and differentiated program outcomes for key populations. Following a program science approach, Partners for Health and Development in Africa, in partnership with the Nairobi County Government and the University of Manitoba, aims to conduct an outcome assessment using a novel, expanded polling booth survey (ePBS) method with female sex workers and men who have sex with men in Nairobi County, Kenya. Objective: This study aims to (1) estimate the incidence and prevalence of HIV; (2) assess biomedical, behavioral, and structural outcomes; and (3) understand barriers contributing to gaps in access and use of available prevention and treatment services among female sex workers and men who have sex with men in Nairobi. Methods: The novel ePBS approach employs complementary data collection methods, expanding upon the traditional polling booth survey (PBS) method by incorporating additional quantitative, qualitative, and biological data collection components and an improved sampling methodology. Quantitative methods will include (1) PBS, a group interview method in which individuals provide responses through a ballot box in an unlinked and anonymous way, and (2) a behavioral and biological survey (BBS), including a face-to-face individual interview and collection of linked biological samples. Qualitative methods will include focus group discussions. The ePBS study uses a 2-stage, population- and location-based random sampling approach involving the random selection of locations from which random participants are selected at a predetermined time on a randomly selected day. PBS data will be analyzed at the group level, and BBS data will be analyzed at an individual level. Qualitative data will be analyzed thematically. Results: Data were collected from April to May 2023. The study has enrolled 759 female sex workers (response rate: 759/769, 98.6%) and 398 men who have sex with men (response rate: 398/420, 94.7%). Data cleaning and analyses are ongoing, with a focus on assessing gaps in program coverage and inequities in program outcomes. Conclusions: The study will generate valuable HIV outcome data to inform program improvement and policy development for Nairobi County?s key population HIV prevention program. This study served as a pilot for the novel ePBS method, which combines PBS, BBS, and focus group discussions to enhance its programmatic utility. The ePBS method holds the potential to fill an acknowledged gap for a rapid, low-cost, and simple method to routinely measure HIV outcomes within programs and inform incremental program improvements through embedded learning processes. UR - https://publichealth.jmir.org/2024/1/e54313 UR - http://dx.doi.org/10.2196/54313 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/54313 ER - TY - JOUR AU - Lelu?iu-Weinberger, Corina AU - Filimon, L. Mircea AU - Hoover, Donald AU - Lixandru, Mihai AU - Hanu, Lucian AU - Dogaru, Bogdan AU - Kovacs, Tudor AU - Fierbin?eanu, Cristina AU - Ionescu, Florentina AU - Manu, Monica AU - Mari?, Alexandra AU - Pan?, Elena AU - Dorob?n?escu, Cristian AU - Streinu-Cercel, Adrian AU - Pachankis, E. John PY - 2024/5/6 TI - An mHealth Intervention for Gay and Bisexual Men?s Mental, Behavioral, and Sexual Health in a High-Stigma, Low-Resource Context (Project Comunic?): Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e52853 VL - 13 KW - gay and bisexual men KW - HIV prevention KW - heavy alcohol use KW - stigma KW - mental health KW - behavioral intervention KW - mobile phone N2 - Background: The World Health Organization reported that 80% of new HIV diagnoses in Europe in 2014 occurred in Central and Eastern Europe. Romania has a particularly high HIV incidence, AIDS prevalence, and number of related deaths. HIV incidence in Romania is largely attributed to sexual contact among gay and bisexual men. However, homophobic stigma in Romania serves as a risk factor for HIV infection for gay and bisexual men. The Comunic? intervention aims to provide a much-needed HIV risk reduction strategy, and it entails the delivery of motivational interviewing and cognitive behavioral therapy skills across 8 live text-based counseling sessions on a mobile platform to gay and bisexual men at risk of HIV. The intervention is based on the information-motivation-behavior and minority stress models. There is preliminary evidence suggesting that Comunic? holds promise for reducing gay and bisexual men?s co-occurring sexual (eg, HIV transmission risk behavior), behavioral (eg, heavy alcohol use), and mental (eg, depression) health risks in Romania. Objective: This paper describes the protocol for a randomized controlled trial designed to test the efficacy of Comunic? in a national trial. Methods: To test Comunic??s efficacy, 305 gay and bisexual men were randomized to receive Comunic? or a content-matched education attention control condition. The control condition consisted of 8 time-matched educational modules that present information regarding gay and bisexual men?s identity development, information about HIV transmission and prevention, the importance of HIV and sexually transmitted infection testing and treatment, heavy alcohol use and its associations with HIV transmission risk behavior, sexual health communication, finding social support, and creating sexual health goals. Participants undergo rapid HIV and syphilis testing and 3-site chlamydia and gonorrhea testing at baseline and the 12-month follow-up. Outcomes are measured before the intervention (baseline) and at the 4-, 8-, and 12-month follow-ups. Results: The study was funded in September 2018, and data collection began in May 2019. The last participant follow-up was in January 2024. Currently, the data analyst is cleaning data sets in preparation for data analyses, which are scheduled to begin in April 2024. Data analysis meetings are scheduled regularly to establish timelines and examine the results as analyses are gradually being conducted. Upon completion, a list of manuscripts will be reviewed and prioritized, and the team will begin preparing them for publication. Conclusions: This study is the first to test the efficacy of an intervention with the potential to simultaneously support the sexual, behavioral, and mental health of gay and bisexual men in Central and Eastern Europe using motivational interviewing support and sensitivity to the high-stigma context of the region. If efficacious, Comunic? presents a scalable platform to provide support to gay and bisexual men living in Romania and similar high-stigma, low-resource countries. Trial Registration: ClinicalTrials.gov NCT03912753; https://clinicaltrials.gov/study/NCT03912753 International Registered Report Identifier (IRRID): DERR1-10.2196/52853 UR - https://www.researchprotocols.org/2024/1/e52853 UR - http://dx.doi.org/10.2196/52853 UR - http://www.ncbi.nlm.nih.gov/pubmed/38709550 ID - info:doi/10.2196/52853 ER - TY - JOUR AU - Ambrosio, Graca Maria Da AU - Lachman, M. Jamie AU - Zinzer, Paula AU - Gwebu, Hlengiwe AU - Vyas, Seema AU - Vallance, Inge AU - Calderon, Francisco AU - Gardner, Frances AU - Markle, Laurie AU - Stern, David AU - Facciola, Chiara AU - Schley, Anne AU - Danisa, Nompumelelo AU - Brukwe, Kanyisile AU - Melendez-Torres, GJ PY - 2024/5/3 TI - A Factorial Randomized Controlled Trial to Optimize User Engagement With a Chatbot-Led Parenting Intervention: Protocol for the ParentText Optimisation Trial JO - JMIR Res Protoc SP - e52145 VL - 13 KW - parenting intervention KW - chatbot-led public health intervention KW - engagement KW - implementation science KW - mobile phone N2 - Background: Violence against children (VAC) is a serious public health concern with long-lasting adverse effects. Evidence-based parenting programs are one effective means to prevent VAC; however, these interventions are not scalable in their typical in-person group format, especially in low- and middle-income countries where the need is greatest. While digital delivery, including via chatbots, offers a scalable and cost-effective means to scale up parenting programs within these settings, it is crucial to understand the key pillars of user engagement to ensure their effective implementation. Objective: This study aims to investigate the most effective and cost-effective combination of external components to optimize user engagement with ParentText, an open-source chatbot-led parenting intervention to prevent VAC in Mpumalanga, South Africa. Methods: This study will use a mixed methods design incorporating a 2 × 2 factorial cluster-randomized controlled trial and qualitative interviews. Parents of adolescent girls (32 clusters, 120 participants [60 parents and 60 girls aged 10 to 17 years] per cluster; N=3840 total participants) will be recruited from the Ehlanzeni and Nkangala districts of Mpumalanga. Clusters will be randomly assigned to receive 1 of the 4 engagement packages that include ParentText alone or combined with in-person sessions and a facilitated WhatsApp support group. Quantitative data collected will include pretest-posttest parent- and adolescent-reported surveys, facilitator-reported implementation data, and digitally tracked engagement data. Qualitative data will be collected from parents and facilitators through in-person or over-the-phone individual semistructured interviews and used to expand the interpretation and understanding of the quantitative findings. Results: Recruitment and data collection started in August 2023 and were finalized in November 2023. The total number of participants enrolled in the study is 1009, with 744 caregivers having completed onboarding to the chatbot-led intervention. Female participants represent 92.96% (938/1009) of the sample population, whereas male participants represent 7.03% (71/1009). The average participant age is 43 (SD 9) years. Conclusions: The ParentText Optimisation Trial is the first study to rigorously test engagement with a chatbot-led parenting intervention in a low- or middle-income country. The results of this study will inform the final selection of external delivery components to support engagement with ParentText in preparation for further evaluation in a randomized controlled trial in 2024. Trial Registration: Open Science Framework (OSF); https://doi.org/10.17605/OSF.IO/WFXNE International Registered Report Identifier (IRRID): DERR1-10.2196/52145 UR - https://www.researchprotocols.org/2024/1/e52145 UR - http://dx.doi.org/10.2196/52145 UR - http://www.ncbi.nlm.nih.gov/pubmed/38700935 ID - info:doi/10.2196/52145 ER - TY - JOUR AU - Aggarwal, Monica AU - Hutchison, G. Brian AU - Kokorelias, M. Kristina AU - Ramsden, R. Vivian AU - Ivers, M. Noah AU - Pinto, Andrew AU - Uphsur, G. Ross E. AU - Wong, T. Sabrina AU - Pimlott, Nick AU - Slade, Steve PY - 2024/4/23 TI - The Conceptualization and Measurement of Research Impact in Primary Health Care: Protocol for a Rapid Scoping Review JO - JMIR Res Protoc SP - e55860 VL - 13 KW - research impact KW - primary health care KW - measurement KW - definition KW - concept KW - development KW - implementation KW - health policy KW - policy KW - health service KW - rapid review KW - review KW - research KW - policies KW - societal KW - productivity KW - literature database N2 - Background: The generation of research evidence and knowledge in primary health care (PHC) is crucial for informing the development and implementation of interventions and innovations and driving health policy, health service improvements, and potential societal changes. PHC research has broad effects on patients, practices, services, population health, community, and policy formulation. The in-depth exploration of the definition and measures of research impact within PHC is essential for broadening our understanding of research impact in the discipline and how it compares to other health services research. Objective: The objectives of the study are (1) to understand the conceptualizations and measures of research impact within the realm of PHC and (2) to identify methodological frameworks for evaluation and research impact and the benefits and challenges of using these approaches. The forthcoming review seeks to guide future research endeavors and enhance methodologies used in assessing research impact within PHC. Methods: The protocol outlines the rapid review and environmental scan approach that will be used to explore research impact in PHC and will be guided by established frameworks such as the Canadian Academy of Health Sciences Impact Framework and the Canadian Health Services and Policy Research Alliance. The rapid review follows scoping review guidelines (PRISMA-ScR; Preferred Reporting Items for Systematic Review and Meta-Analysis Extension for Scoping Reviews). The environmental scan will be done by consulting with professional organizations, academic institutions, information science, and PHC experts. The search strategy will involve multiple databases, citation and forward citation searching, and manual searches of gray literature databases, think tank websites, and relevant catalogs. We will include gray and scientific literature focusing explicitly on research impact in PHC from high-income countries using the World Bank classification. Publications published in English from 1978 will be considered. The collected papers will undergo a 2-stage independent review process based on predetermined inclusion criteria. The research team will extract data from selected studies based on the research questions and the CRISP (Consensus Reporting Items for Studies in Primary Care) protocol statement. The team will discuss the extracted data, enabling the identification and categorization of key themes regarding research impact conceptualization and measurement in PHC. The narrative synthesis will evolve iteratively based on the identified literature. Results: The results of this study are expected at the end of 2024. Conclusions: The forthcoming review will explore the conceptualization and measurement of research impact in PHC. The synthesis will offer crucial insights that will guide subsequent research, emphasizing the need for a standardized approach that incorporates diverse perspectives to comprehensively gauge the true impact of PHC research. Furthermore, trends and gaps in current methodologies will set the stage for future studies aimed at enhancing our understanding and measurement of research impact in PHC. International Registered Report Identifier (IRRID): PRR1-10.2196/55860 UR - https://www.researchprotocols.org/2024/1/e55860 UR - http://dx.doi.org/10.2196/55860 UR - http://www.ncbi.nlm.nih.gov/pubmed/38652900 ID - info:doi/10.2196/55860 ER - TY - JOUR AU - Jockers, Dominik AU - Bakoubayi, Wimima Akila AU - Bärnighausen, Kate AU - Bando, P'kontème P'tanam AU - Pechar, Stefanie AU - Maina, Wamuyu Teresia AU - Wachinger, Jonas AU - Vetter, Mark AU - Djakpa, Yawovi AU - Saka, Bayaki AU - Gnossike, Piham AU - Schröder, Maike Nora AU - Liu, Shuyan AU - Gadah, Yawovi Denis Agbenyigan AU - Kasang, Christa AU - Bärnighausen, Till PY - 2024/4/18 TI - Effectiveness of Sensitization Campaigns in Reducing Leprosy-Related Stigma in Rural Togo: Protocol for a Mixed Methods Cluster Randomized Controlled Trial JO - JMIR Res Protoc SP - e52106 VL - 13 KW - audio KW - community health worker KW - information campaign KW - knowledge, attitude, and practices KW - language KW - leprosy-related stigma KW - qualitative and quantitative research KW - stigma intervention KW - Togo KW - West Africa N2 - Background: In the global strategy to eliminate leprosy, there remains a need for early case detection to successfully interrupt transmissions. Poor knowledge about leprosy and leprosy-related stigma are key drivers of delayed diagnosis and treatment. Sensitization campaigns to inform and increase awareness among the general population are an integral part of many national neglected tropical disease programs. Despite their importance, the effectiveness of such campaigns has not been rigorously studied in the West African context. A multilingual rural setting with low health literacy in this region presents challenges to the potential impact of sensitization campaigns. Objective: The primary objective of this study is to assess the causal effect of common practice community sensitization campaigns on leprosy-related knowledge and stigma at the community level and among community health volunteers. Additionally, we will test the potential of novel educational audio tools in the 15 most prominent local languages to overcome literacy and language barriers and amplify sensitization campaigns. Methods: We will conduct a cluster randomized controlled trial using a sequential mixed methods approach in 60 rural communities across all regions of Togo, West Africa. The study features 2 intervention arms and 1 control arm, with intervention and control assignments made at the community level through randomization. Communities in intervention arm 1 will receive a sensitization campaign in line with the current Togolese national neglected tropical disease program. Communities in intervention arm 2 will receive the same sensitization campaign along with educational audio tools distributed to community households. The control arm will receive no intervention before data collection. Quantitative outcome measures on knowledge and stigma will be collected from a random sample of 1200 individuals. Knowledge will be assessed using the 9-item standardized Knowledge, Attitudes, and Practices Questionnaire. Stigma will be measured using the 7-item Social Distance Scale and the 15-item Explanatory Model Interview Catalogue Community Stigma Scale. We will estimate intention-to-treat effects at the individual level, comparing the outcomes of the intervention and control arms. In an accompanying qualitative component, we will conduct in-depth interviews with community members, community health volunteers, and health care workers in both treatment arms and the control arm to explore intervention and stigma-related experiences. Results: This paper describes and discusses the protocol for a mixed methods cluster randomized controlled trial. Data collection is planned to be completed in June 2024, with ongoing data analysis. The first results are expected to be submitted for publication by the end of 2024. Conclusions: This trial will be among the first to test the causal effectiveness of community-based sensitization campaigns and audio tools to increase knowledge and reduce leprosy-related stigma. As such, the results will inform health policy makers, decision-makers, and public health practitioners designing sensitization campaigns in rural multilingual settings. Trial Registration: German Clinical Trials Register DRKS00029355; https://drks.de/search/en/trial/DRKS00029355 International Registered Report Identifier (IRRID): DERR1-10.2196/52106 UR - https://www.researchprotocols.org/2024/1/e52106 UR - http://dx.doi.org/10.2196/52106 UR - http://www.ncbi.nlm.nih.gov/pubmed/38635983 ID - info:doi/10.2196/52106 ER - TY - JOUR AU - Galli, Anaïs AU - Ma'ani Abuzahra, Yaman AU - Bänziger, Carola AU - Ballo, Aboubacar AU - Friedrich, D. Max N. AU - Gross, Karin AU - Harter, Miriam AU - Hattendorf, Jan AU - Peter, Maryna AU - Tamas, Andrea AU - Owen, N. Branwen AU - Winkler, S. Mirko PY - 2024/4/3 TI - Assessing the Effectiveness of a Multicomponent Intervention on Hand Hygiene and Well-Being in Primary Health Care Centers and Schools Lacking Functional Water Supply in Protracted Conflict Settings: Protocol for a Cluster Randomized Controlled Trial JO - JMIR Res Protoc SP - e52959 VL - 13 KW - water, sanitation, and hygiene KW - WASH KW - hand hygiene KW - impact evaluation KW - conflict settings KW - behavior change KW - handwashing KW - students KW - handwashing stations KW - primary schools, primary health care facilities KW - humanitarian crisis KW - mobile phone N2 - Background: Hand hygiene is crucial in health care centers and schools to avoid disease transmission. Currently, little is known about hand hygiene in such facilities in protracted conflict settings. Objective: This protocol aims to assess the effectiveness of a multicomponent hand hygiene intervention on handwashing behavior, underlying behavioral factors, and the well-being of health care workers and students. Moreover, we report our methodology and statistical analysis plan transparently. Methods: This is a cluster randomized controlled trial with 2 parallel arms taking place in 4 countries for 1 year. In Burkina Faso and Mali, we worked in 24 primary health care centers per country, whereas in Nigeria and Palestine, we focused on 26 primary schools per country. Facilities were eligible if they were not connected to a functioning water source but were deemed accessible to the implementation partners. Moreover, health care centers were eligible if they had a maternity ward and ?5 employees, and schools if they had ?7000 students studying in grades 5 to 7. We used covariate-constrained randomization to assign intervention facilities that received a hardware, management and monitoring support, and behavior change. Control facilities will receive the same or improved intervention after endline data collection. To evaluate the intervention, at baseline and endline, we used a self-reported survey, structured handwashing observations, and hand-rinse samples. At follow-up, hand-rinse samples were dropped. Starting from the intervention implementation, we collected longitudinal data on hygiene-related health conditions and absenteeism. We also collected qualitative data with focus group discussions and interviews. Data were analyzed descriptively and with random effect regression models with the random effect at a cluster level. The primary outcome for health centers is the handwashing rate, defined as the number of times health care workers performed good handwashing practice with soap or alcohol-based handrub at one of the World Health Organization 5 moments for hand hygiene, divided by the number of moments for hand hygiene that presented themselves during the patient interaction within an hour of observation. For schools, the primary outcome is the number of students who washed their hands before eating. Results: The baseline data collection across all countries lasted from February to June 2023. We collected data from 135 and 174 health care workers in Burkina Faso and Mali, respectively. In Nigeria, we collected data from 1300 students and in Palestine from 1127 students. The endline data collection began in February 2024. Conclusions: This is one of the first studies investigating hand hygiene in primary health care centers and schools in protracted conflict settings. With our strong study design, we expect to support local policy makers and humanitarian organizations in developing sustainable agendas for hygiene promotion. Trial Registration: ClinicalTrials.gov NCT05946980 (Burkina Faso and Mali); https://www.clinicaltrials.gov/study/NCT05946980 and NCT05964478 (Nigeria and Palestine); https://www.clinicaltrials.gov/study/NCT05964478 International Registered Report Identifier (IRRID): DERR1-10.2196/52959 UR - https://www.researchprotocols.org/2024/1/e52959 UR - http://dx.doi.org/10.2196/52959 UR - http://www.ncbi.nlm.nih.gov/pubmed/38569182 ID - info:doi/10.2196/52959 ER - TY - JOUR AU - Gu, Xinchun AU - Watson, Conall AU - Agrawal, Utkarsh AU - Whitaker, Heather AU - Elson, H. William AU - Anand, Sneha AU - Borrow, Ray AU - Buckingham, Anna AU - Button, Elizabeth AU - Curtis, Lottie AU - Dunn, Dominic AU - Elliot, J. Alex AU - Ferreira, Filipa AU - Goudie, Rosalind AU - Hoang, Uy AU - Hoschler, Katja AU - Jamie, Gavin AU - Kar, Debasish AU - Kele, Beatrix AU - Leston, Meredith AU - Linley, Ezra AU - Macartney, Jack AU - Marsden, L. Gemma AU - Okusi, Cecilia AU - Parvizi, Omid AU - Quinot, Catherine AU - Sebastianpillai, Praveen AU - Sexton, Vanashree AU - Smith, Gillian AU - Suli, Timea AU - Thomas, B. Nicholas P. AU - Thompson, Catherine AU - Todkill, Daniel AU - Wimalaratna, Rashmi AU - Inada-Kim, Matthew AU - Andrews, Nick AU - Tzortziou-Brown, Victoria AU - Byford, Rachel AU - Zambon, Maria AU - Lopez-Bernal, Jamie AU - de Lusignan, Simon PY - 2024/4/3 TI - Postpandemic Sentinel Surveillance of Respiratory Diseases in the Context of the World Health Organization Mosaic Framework: Protocol for a Development and Evaluation Study Involving the English Primary Care Network 2023-2024 JO - JMIR Public Health Surveill SP - e52047 VL - 10 KW - sentinel surveillance KW - pandemic KW - COVID-19 KW - human influenza KW - influenza vaccines KW - respiratory tract infections KW - vaccination KW - World Health Organization KW - respiratory syncytial virus KW - phenotype KW - computerized medical record system N2 - Background: Prepandemic sentinel surveillance focused on improved management of winter pressures, with influenza-like illness (ILI) being the key clinical indicator. The World Health Organization (WHO) global standards for influenza surveillance include monitoring acute respiratory infection (ARI) and ILI. The WHO?s mosaic framework recommends that the surveillance strategies of countries include the virological monitoring of respiratory viruses with pandemic potential such as influenza. The Oxford-Royal College of General Practitioner Research and Surveillance Centre (RSC) in collaboration with the UK Health Security Agency (UKHSA) has provided sentinel surveillance since 1967, including virology since 1993. Objective: We aim to describe the RSC?s plans for sentinel surveillance in the 2023-2024 season and evaluate these plans against the WHO mosaic framework. Methods: Our approach, which includes patient and public involvement, contributes to surveillance objectives across all 3 domains of the mosaic framework. We will generate an ARI phenotype to enable reporting of this indicator in addition to ILI. These data will support UKHSA?s sentinel surveillance, including vaccine effectiveness and burden of disease studies. The panel of virology tests analyzed in UKHSA?s reference laboratory will remain unchanged, with additional plans for point-of-care testing, pneumococcus testing, and asymptomatic screening. Our sampling framework for serological surveillance will provide greater representativeness and more samples from younger people. We will create a biomedical resource that enables linkage between clinical data held in the RSC and virology data, including sequencing data, held by the UKHSA. We describe the governance framework for the RSC. Results: We are co-designing our communication about data sharing and sampling, contextualized by the mosaic framework, with national and general practice patient and public involvement groups. We present our ARI digital phenotype and the key data RSC network members are requested to include in computerized medical records. We will share data with the UKHSA to report vaccine effectiveness for COVID-19 and influenza, assess the disease burden of respiratory syncytial virus, and perform syndromic surveillance. Virological surveillance will include COVID-19, influenza, respiratory syncytial virus, and other common respiratory viruses. We plan to pilot point-of-care testing for group A streptococcus, urine tests for pneumococcus, and asymptomatic testing. We will integrate test requests and results with the laboratory-computerized medical record system. A biomedical resource will enable research linking clinical data to virology data. The legal basis for the RSC?s pseudonymized data extract is The Health Service (Control of Patient Information) Regulations 2002, and all nonsurveillance uses require research ethics approval. Conclusions: The RSC extended its surveillance activities to meet more but not all of the mosaic framework?s objectives. We have introduced an ARI indicator. We seek to expand our surveillance scope and could do more around transmissibility and the benefits and risks of nonvaccine therapies. UR - https://publichealth.jmir.org/2024/1/e52047 UR - http://dx.doi.org/10.2196/52047 UR - http://www.ncbi.nlm.nih.gov/pubmed/38569175 ID - info:doi/10.2196/52047 ER - TY - JOUR AU - Brooks Carthon, Margo J. AU - Brom, Heather AU - Grantham-Murrillo, Marsha AU - Sliwinski, Kathy AU - Mason, Aleigha AU - Roeser, Mindi AU - Miles, Donna AU - Garcia, Dianne AU - Bennett, Jovan AU - Harhay, O. Michael AU - Flores, Emilia AU - Amenyedor, Kelvin AU - Clark, Rebecca PY - 2024/3/26 TI - Equity-Centered Postdischarge Support for Medicaid-Insured People: Protocol for a Type 1 Hybrid Effectiveness-Implementation Stepped Wedge Cluster Randomized Controlled Trial JO - JMIR Res Protoc SP - e54211 VL - 13 KW - health care disparities KW - evidence-based practice KW - Medicaid KW - transitional care KW - implementation science KW - socioeconomic disparities in health N2 - Background: Disparities in posthospitalization outcomes for people with chronic medical conditions and insured by Medicaid are well documented, yet interventions that mitigate them are lacking. Prevailing transitional care interventions narrowly target people aged 65 years and older, with specific disease processes, or limitedly focus on individual-level behavioral change such as self-care or symptom management, thus failing to adequately provide a holistic approach to ensure an optimal posthospital care continuum. This study evaluates the implementation of THRIVE?an evidence-based, equity-focused clinical pathway that supports Medicaid-insured individuals with multiple chronic conditions transitioning from hospital to home by focusing on the social determinants of health and systemic and structural barriers in health care delivery. THRIVE services include coordinating care, standardizing interdisciplinary communication, and addressing unmet clinical and social needs following hospital discharge. Objective: The study?s objectives are to (1) examine referral patterns, 30-day readmission, and emergency department use for participants who receive THRIVE support services compared to those receiving usual care and (2) evaluate the implementation of the THRIVE clinical pathway, including fidelity, feasibility, appropriateness, and acceptability. Methods: We will perform a sequential randomized rollout of THRIVE to case managers at the study hospital in 3 steps (4 in the first group, 4 in the second, and 5 in the third), and data collection will occur over 18 months. Inclusion criteria for THRIVE participation include (1) being Medicaid insured, dually enrolled in Medicaid and Medicare, or Medicaid eligible; (2) residing in Philadelphia; (3) having experienced a hospitalization at the study hospital for more than 24 hours with a planned discharge to home; (4) agreeing to home care at partner home care settings; and (5) being aged 18 years or older. Qualitative data will include interviews with clinicians involved in THRIVE, and quantitative data on health service use (ie, 30-day readmission, emergency department use, and primary and specialty care) will be derived from the electronic health record. Results: This project was funded in January 2023 and approved by the institutional review board on March 10, 2023. Data collection will occur from March 2023 to July 2024. Results are expected to be published in 2025. Conclusions: The THRIVE clinical pathway aims to reduce disparities and improve postdischarge care transitions for Medicaid-insured patients through a system-level intervention that is acceptable for THRIVE participants, clinicians, and their teams in hospitals and home care settings. By using our equity-focused case management services and leveraging the power of the electronic medical record, THRIVE creates efficiencies by identifying high-need patients, improving communication across acute and community-based sectors, and driving evidence-based care coordination. This study will add important findings about how the infusion of equity-focused principles in the design and evaluation of evidence-based interventions contributes to both implementation and effectiveness outcomes. International Registered Report Identifier (IRRID): DERR1-10.2196/54211 Trial Registration: ClinicalTrials.gov NCT05714605; https://clinicaltrials.gov/ct2/show/NCT05714605 UR - https://www.researchprotocols.org/2024/1/e54211 UR - http://dx.doi.org/10.2196/54211 UR - http://www.ncbi.nlm.nih.gov/pubmed/38530349 ID - info:doi/10.2196/54211 ER - TY - JOUR AU - Kitahiro, Yumi AU - Yamamoto, Kazuhiro AU - Yakushijin, Kimikazu AU - Ioroi, Takeshi AU - Tanda, Masaaki AU - Itohara, Kotaro AU - Omura, Tomohiro AU - Minami, Hironobu AU - Yano, Ikuko PY - 2024/2/22 TI - The Efficacy of Bepotastine Besilate Compared With Hydroxyzine Pamoate for Preventing Infusion Reactions to the First Dose of Rituximab in Patients With Non-Hodgkin Lymphoma: Protocol for a Phase II, Double-Blind, Multicenter Randomized Trial JO - JMIR Res Protoc SP - e54882 VL - 13 KW - non-Hodgkin lymphoma KW - rituximab KW - infusion reactions KW - bepotastine besilate KW - histamine H1-receptor antagonist KW - hydroxyzine pamoate KW - drowsiness N2 - Background: Rituximab, an anti-CD20 monoclonal antibody, can cause infusion reactions (IRs), especially during the initial rituximab infusion therapy. Generally, patients are administered a histamine H1-receptor antagonist before the rituximab infusion, along with an antipyretic analgesic, to prevent or reduce IRs. Multiple retrospective case-control studies indicate that the second generation of histamine H1-receptor antagonists might be more effective than the first generation in suppressing IRs caused by the rituximab infusion. Objective: This study aimed to assess the efficacy of first- and second-generation histamine H1-receptor antagonists for preventing IRs resulting from the initial infusion of rituximab in patients diagnosed with non-Hodgkin lymphoma. Methods: This is a phase II, double-blind, active-controlled randomized trial. It will be a multicenter study conducted across 3 facilities that aims to enroll a total of 40 patients diagnosed with non-Hodgkin lymphoma who will receive their initial rituximab infusion. Participating patients will be administered hydroxyzine pamoate or bepotastine besilate, representing first- or second-generation histamine H1-receptor antagonists, respectively. This will be combined with 400-mg acetaminophen tablets taken approximately 30 minutes before the first infusion of rituximab. The primary end point of this trial is to assess severe IRs, equivalent to grade 2 or higher as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0, that occur within a 4-hour period after the initiation of rituximab infusion. The secondary end points include assessing the severity of the initial IR, the maximum severity of the IR, and the duration between rituximab infusion initiation and the onset of the first IR within a 4-hour period. Additionally, the trial will evaluate histamine H1-receptor antagonist?induced drowsiness using the visual analogue scale, with each patient providing their individual response. Results: This study began with patient recruitment in April 2023, with 17 participants enrolled as of November 12, 2023. The anticipated study completion is set for February 2026. Conclusions: This study is the first randomized controlled trial comparing the effects of oral first- and second-generation histamine H1-receptor antagonists in preventing IRs induced by the initial administration of rituximab. The findings from this study hold the potential to establish the rationale for a phase III study aimed at determining the standard premedication protocol for rituximab infusion. Trial Registration: Japan Registry of Clinical Trials jRCTs051220169; https://jrct.niph.go.jp/latest-detail/jRCTs051220169 International Registered Report Identifier (IRRID): DERR1-10.2196/54882 UR - https://www.researchprotocols.org/2024/1/e54882 UR - http://dx.doi.org/10.2196/54882 UR - http://www.ncbi.nlm.nih.gov/pubmed/38386393 ID - info:doi/10.2196/54882 ER - TY - JOUR AU - Mukherjee, Joyeeta AU - Rawat, Shruta AU - ul Hadi, Saif AU - Aggarwal, Pritha AU - Chakrapani, Venkatesan AU - Rath, Pratyasha AU - Manchi, Pallavi AU - Aylur, Srikrishnan AU - Malhotra, Shelly AU - Keane, Margaret AU - Gangaramany, Alok PY - 2024/2/7 TI - Understanding the Acceptability of Broadly Neutralizing Antibodies for HIV Prevention Among At-Risk Populations and Feasibility Considerations for Product Introduction in India: Protocol for a Qualitative Study JO - JMIR Res Protoc SP - e47700 VL - 13 KW - HIV KW - key populations KW - acceptability KW - feasibility KW - product attributes KW - end-user preferences KW - broadly neutralizing antibodies KW - simulated behavioral experiments KW - qualitative study N2 - Background: Acceptability and preference research play a crucial role in the design, evaluation, and implementation of any new prevention product in any geographical setting. They also play a critical role in the development of clinical guidelines and policies. A wide range of acceptability studies have been conducted in diverse general and key populations for various new HIV prevention products worldwide. As clinical development strategies are being developed for clinical studies of broadly neutralizing antibodies (bNAbs) as potential HIV prevention products, appropriately tailoring them to address the type of HIV epidemic at hand would be critical for efficient uptake within in-country public health systems and decrease adoption and adherence challenges. Accomplishing this will require comprehensive acceptability and feasibility studies to inform multisectoral efforts that increase access to these products and national policies supportive of access to health care for those in most need. Thus, it is both opportune and important to undertake focused efforts toward informing product development strategies. Objective: This study aims to understand preferences for product attributes and key behavioral factors influencing adoption and uptake of bNAb prevention products among end-users including female sex workers, men who have sex with men, transgender women, people who inject drugs, and adolescent girls and young women in India and understand the key health system and programmatic perspectives toward the introduction of bNAb prevention products from health service providers and policy makers in India. Methods: A multisite study will be conducted in Delhi, Mumbai, and Chennai to capture the differences in perspectives among diverse end-users and key informants across the country. The study will use a multimethods design using focus group discussions, in-depth interviews, simulated behavioral experiments, and key informant interviews. A total of 30 focus group discussions, 45 in-depth interviews, 15 simulated behavioral experiments sessions, and 15 key informant interviews will be conducted across 3 sites. Results: The data collected and analyzed will enable insights on which specific product attributes matter the most to the populations and why some attributes are less preferred; contextual drivers of preferences and choices at individual, interpersonal, social, and structural levels; and relative positioning of bNAb products among other potential HIV prevention products. Insights from the health service providers and policy makers will provide a critical understanding of the need perception of the potential product in the existing product landscape and what additional efforts and resources are required for potential introduction, delivery, and uptake of the bNAb products in the Indian context. Conclusions: Insights generated from the abovementioned objectives will represent perspectives of populations of interest across geographies in India, will provide an overview of the acceptability of bNAb products and the feasibility of their introduction in this region, and will inform product development strategies. International Registered Report Identifier (IRRID): DERR1-10.2196/47700 UR - https://www.researchprotocols.org/2024/1/e47700 UR - http://dx.doi.org/10.2196/47700 UR - http://www.ncbi.nlm.nih.gov/pubmed/38324364 ID - info:doi/10.2196/47700 ER - TY - JOUR AU - Abd Kadir, Aziah Nor AU - Azzeri, Amirah AU - Jaafar, Hafiz AU - Mohd Noor, Iqbal Mohd AU - Kefeli, Zurina PY - 2024/1/29 TI - The Impact of the Ecosystem on Health Literacy Among Rural Communities in Protected Areas: Protocol for a Mixed Methods Study JO - JMIR Res Protoc SP - e51851 VL - 13 KW - ecosystem KW - health literacy KW - protected areas KW - Net-Map KW - quality of life KW - rural communities KW - protocol N2 - Background: Protected areas are crucial for the maintenance of human health and well-being. They aim to preserve biodiversity and natural resources to secure various ecosystem services that are beneficial to human health. Their ecological characteristics can influence local health literacy. Typically, communities surrounding protected areas have limited economic opportunities due to restriction policies to protect the ecosystem, resulting in socioeconomic disparities. The local community faces obstacles in gaining access to health care facilities and health information due to these limitations. It is difficult for them to locate, comprehend, and apply information and services to make better health-related decisions for themselves and others. Objective: This study protocol examines the impact of the ecosystem on health literacy among rural communities in protected areas. Methods: This study comprises 5 phases. In phase 1, we conduct a systematic review to identify the issue of health literacy in protected areas. In phase 2, we will collect data from stakeholders in a protected area of Pahang National Park and analyze the results using Net-Map analysis. In phase 3, we will conduct a survey among the adult community in Pahang National Park related to health literacy, socioeconomic status, health expenditure, and quality of life. In phase 4, informed by the results of the survey, we will determine suitable intervention programs to improve health literacy through a focus group discussion. Finally, in phase 5, we will conduct a costing analysis to analyze which intervention program is the most cost-effective. Results: This study was funded by Universiti Sains Islam Malaysia (USIM) and strategic research partnership grants, and enrollment is ongoing. The first results are expected to be submitted for publication in 2024. Conclusions: This is one of the first studies to explore health literacy among rural communities in protected areas and will provide the first insights into the overall level of health literacy in the protected community, potential determinants, and a suitable intervention program with expected cost analysis. The results can be used to promote health literacy in other protected areas and populations. Trial Registration: International Standard Randomized Controlled Trial Number Registry ISRCTN40626062; http://tinyurl.com/4kjxuwk5 International Registered Report Identifier (IRRID): PRR1-10.2196/51851 UR - https://www.researchprotocols.org/2024/1/e51851 UR - http://dx.doi.org/10.2196/51851 UR - http://www.ncbi.nlm.nih.gov/pubmed/38285500 ID - info:doi/10.2196/51851 ER - TY - JOUR AU - Knox, R. Justin AU - Dolotina, Brett AU - Moline, Tyrone AU - Matthews, Isabella AU - Durrell, Mainza AU - Hanson, Hillary AU - Almirol, Ellen AU - Hotton, Anna AU - Pagkas-Bather, Jade AU - Chen, Yen-Tyng AU - English, Devin AU - Manuzak, Jennifer AU - Rower, E. Joseph AU - Miles, Caleb AU - Millar, Brett AU - Jean-Louis, Girardin AU - Rendina, Jonathon H. AU - Martins, S. Silvia AU - Grov, Christian AU - Hasin, S. Deborah AU - Carrico, W. Adam AU - Shoptaw, Steve AU - Schneider, A. John AU - Duncan, T. Dustin PY - 2023/12/1 TI - HIV Prevention and Care Among Black Cisgender Sexual Minority Men and Transgender Women: Protocol for an HIV Status?Neutral Cohort Study Using an Observational-Implementation Hybrid Approach JO - JMIR Res Protoc SP - e48548 VL - 12 KW - HIV KW - cisgender sexual minority men KW - transgender women KW - Black KW - African American KW - cannabis KW - sleep KW - stimulants KW - substance use KW - alcohol N2 - Background: Black cisgender gay, bisexual, and other sexual minority men (SMM) and transgender women (TW) continue to be heavily affected by HIV. Further research is needed to better understand HIV prevention and care outcomes in this population. In particular, there is a need for research examining the impact of substance use and sleep health on HIV prevention and treatment outcomes among Black SMM and TW. Objective: This paper outlines the study methods being used in the recently launched follow-up study to the Neighborhoods and Networks (N2) study, which we refer to as N2 Part 2 (N2P2). N2P2 aims to address this gap in the literature, build off the findings of the original N2 study, and identify socioenvironmental determinants of health, including whether neighborhood and network factors mediate and moderate these relationships. Methods: Building on the N2 cohort study in Chicago from 2018 to 2022, N2P2 used a prospective longitudinal cohort design and an observational-implementation hybrid approach. With sustained high levels of community engagement, we aim to recruit a new sample of 600 Black SMM and TW participants residing in the Chicago metropolitan statistical area. Participants are asked to participate in 3 study visits across an 18-month study period (1 visit every 9 months). Four different forms of data are collected per wave: (1) an in-person survey, (2) biological specimen collection, (3) a daily remote ecological momentary assessment for 14 days after each study visit, and (4) data from electronic health records. These forms of data collection continue to assess neighborhood and network factors and specifically explore substance use, sleep, immune function, obesity, and the implementation of potential interventions that address relevant constructs (eg, alcohol use and pre-exposure prophylaxis adherence). Results: The N2P2 study was funded in August 2021 by the National Institute of Drug Abuse (R01DA054553 and R21DA053156) and National Heart, Lung, and Blood Institute (R01HL160325). This study was launched in November 2022. Recruitment and enrollment for the first wave of data collection are currently ongoing. Conclusions: The N2P2 study is applying innovative methods to comprehensively explore the impacts of substance use and sleep health on HIV-related outcomes among an HIV status?neutral cohort of Black SMM and TW in Chicago. This study is applying an observational-implementation hybrid design to help us achieve findings that support rapid translation, a critical priority among populations such as Black SMM and TW that experience long-standing inequities with regard to HIV and other health-related outcomes. N2P2 will directly build off the findings that have resulted from the original N2 study among Black SMM and TW in Chicago. These findings provide a better understanding of multilevel (eg, individual, network, and neighborhood) factors that contribute to HIV-related outcomes and viral suppression among Black SMM and TW. International Registered Report Identifier (IRRID): DERR1-10.2196/48548 UR - https://www.researchprotocols.org/2023/1/e48548 UR - http://dx.doi.org/10.2196/48548 UR - http://www.ncbi.nlm.nih.gov/pubmed/38039075 ID - info:doi/10.2196/48548 ER - TY - JOUR AU - Meza-Torres, Bernardo AU - Forbes, Anna AU - Elson, William AU - Kar, Debasish AU - Jamie, Gavin AU - Hinton, William AU - Fan, Xuejuan AU - Byford, Rachel AU - Feher, Michael AU - Whyte, Martin AU - Joy, Mark AU - de Lusignan, Simon PY - 2023/10/24 TI - Hepatitis A Vaccination Coverage Among People With Chronic Liver Disease in England (HEALD): Protocol for a Retrospective Cohort Study JO - JMIR Res Protoc SP - e51861 VL - 12 KW - chronic liver disease KW - computerized KW - data accuracy KW - data extract KW - ethnicity KW - fatty liver disease KW - general practitioner KW - hepatitis A vaccination KW - hepatitis KW - liver disease KW - medical record systems KW - primary care KW - routine data sets KW - Systematized Nomenclature of Medicine KW - vaccination monitoring and surveillance KW - vaccination N2 - Background: Hepatitis A outbreaks in the United Kingdom are uncommon. Most people develop mild to moderate symptoms that resolve, without sequelae, within months. However, in high-risk groups, including those with underlying chronic liver disease (CLD), hepatitis A infection can be severe, with a higher risk of mortality and morbidity. The Health Security Agency and the National Institute of Health and Care Excellence recommend preexposure hepatitis A vaccination given in 2 doses to people with CLD, regardless of its cause. There are currently no published reports of vaccination coverage for people with CLD in England or internationally. Objective: This study aims to describe hepatitis A vaccination coverage in adults with CLD in a UK primary care setting and compare liver disease etiology, sociodemographic characteristics, and comorbidities in people who are and are not exposed to the hepatitis A vaccine. Methods: We will conduct a retrospective cohort study with data from the Primary Care Sentinel Cohort of the Oxford-Royal College of General Practitioners Clinical Informatics Digital Hub database, which is nationally representative of the English population. We will include people aged 18 years and older who have been registered in general practices in the Research and Surveillance Centre network and have a record of CLD between January 1, 2012, and December 31, 2022, including those with alcohol-related liver disease, chronic hepatitis B, chronic hepatitis C, nonalcohol fatty liver disease, Wilson disease, hemochromatosis, and autoimmune hepatitis. We will carefully curate variables using the Systematized Nomenclature of Medicine Clinical Terms. We will report the sociodemographic characteristics of those who are vaccinated. These include age, gender, ethnicity, population density, region, socioeconomic status (measured using the index of multiple deprivation), obesity, alcohol consumption, and smoking. Hepatitis A vaccination coverage for 1 and 2 doses will be calculated using an estimate of the CLD population as the denominator. We will analyze the baseline characteristics using descriptive statistics, including measures of dispersion. Pairwise comparisons of case-mix characteristics, comorbidities, and complications will be reported according to vaccination status. A multistate survival model will be fitted to estimate the transition probabilities among four states: (1) diagnosed with CLD, (2) first dose of hepatitis A vaccination, (3) second dose of hepatitis A vaccination, and (4) death. This will identify any potential disparities in how people with CLD get vaccinated. Results: The Research and Surveillance Centre population comprises over 8 million people. The reported incidence of CLD is 20.7 cases per 100,000. International estimates of hepatitis A vaccine coverage vary between 10% and 50% in this group. Conclusions: This study will describe the uptake of the hepatitis A vaccine in people with CLD and report any disparities or differences in the characteristics of the vaccinated population. International Registered Report Identifier (IRRID): PRR1-10.2196/51861 UR - https://www.researchprotocols.org/2023/1/e51861 UR - http://dx.doi.org/10.2196/51861 UR - http://www.ncbi.nlm.nih.gov/pubmed/37874614 ID - info:doi/10.2196/51861 ER - TY - JOUR AU - Bhatta, Mihir AU - Majumdar, Agniva AU - Banerjee, Sitikantha AU - Ghosh, Piyali AU - Biswas, Subrata AU - Dutta, Shanta PY - 2023/6/19 TI - Accumulation of Biological and Behavioral Data of Female Sex Workers Using Respondent-Driven Sampling: Protocol for a Systematic Review JO - JMIR Res Protoc SP - e43722 VL - 12 KW - respondent-driven sampling KW - RDS KW - female sex worker KW - FSW KW - systematic review KW - review method KW - sex worker KW - sampling method KW - sample design N2 - Background: Respondent-driven sampling (RDS) is a nonprobability sampling technique that allows the extrapolation of its outcome to the target population. This approach is typically used to overcome the difficulties in studying hidden or difficult-to-reach groups. Objective: The purpose of this protocol is to generate a systematic review on the accumulation of biological and behavioral data of female sex workers (FSWs) through different surveys that use the RDS method from around the world in the near future. The future systematic review will discuss the initiation, actualization, and problems of RDS during the accumulation of biological and behavioral data of FSWs through surveys from around the world. Methods: The behavior and biological data of FSWs will be extracted from peer-reviewed studies published between 2010 and 2022 and that are acquired through RDS. Using PubMed, Google Scholar, the Cochrane database, Scopus, Science Direct, and the Global Health network, all papers that are available will be obtained using the search phrases ?respondent-driven? and ?Female Sex Workers? OR ?FSW? OR ?sex workers? OR ?SW.? According to STROBE-RDS (Strengthening the Reporting of Observational Studies in Epidemiology for Respondent-Driven Sampling) criteria, the data will be retrieved through a data extraction form and will be organized using World Health Organization classifications of areas. The Newcastle-Ottawa Quality Assessment Scale will be used to measure bias risk and overall study quality. Results: The future systematic review that will be generated from this protocol will offer evidence for or against the claim that using the RDS technique to recruit participants from ?hidden? or ?hard-to-reach? populations is the best strategy. The results will be disseminated through a peer-reviewed publication. Data collection started on April 1, 2023, and the systematic review is expected to be published by December 15, 2023. Conclusions: A minimum set of parameters for specific methodological, analytical, and testing procedures, including RDS methods to evaluate the overall quality of any RDS survey, will be provided by the future systematic review, in accordance with this protocol, to assist researchers, policy makers, and service providers in improving RDS methods for the surveillance of any key population. Trial Registration: PROSPERO CRD42022346470; https://tinyurl.com/54xe2s3k International Registered Report Identifier (IRRID): DERR1-10.2196/43722 UR - https://www.researchprotocols.org/2023/1/e43722 UR - http://dx.doi.org/10.2196/43722 UR - http://www.ncbi.nlm.nih.gov/pubmed/37335607 ID - info:doi/10.2196/43722 ER - TY - JOUR AU - Manton, Danielle AU - Williams, Megan AU - Hayen, Andrew PY - 2023/5/18 TI - The Bunya Project: Protocol for a Mixed-Methods Approach to Developing a Culturally Informed Curriculum JO - JMIR Res Protoc SP - e39864 VL - 12 KW - Indigenous KW - university KW - curriculum KW - leadership KW - cocreation KW - self-determination N2 - Background: Indigenous peoples live across all continents, representing approximately 90 nations and cultures and 476 million people. There have long been clear statements about the rights of Indigenous peoples to self-determine services, policies, and resource allocations that affect our lives, particularly via the United Nations Declaration on the Rights of Indigenous Peoples. An area for urgent improvement is curricula that train the predominantly non-Indigenous health workforce about their responsibilities and that offer practical strategies to use when engaging with Indigenous peoples and issues. Objective: The Bunya Project is designed to advance Indigenous community-led teaching and evaluation of the embeddedness of strategies to achieve an Indigenous Graduate Attribute in Australia. The project centers the relationships with Aboriginal community services to lead education design relating to Indigenous peoples. The project aims to articulate community recommendations for university education in allied health in the usable format of digital stories to create culturally informed andragogy, curriculum, and assessment measures for use in teaching. It also aims to understand the impact of this work on student attitudes and knowledge about Indigenous peoples? allied health needs. Methods: Multilayered project governance was established, along with a 2-stage process using mixed methods participatory action research and critical reflection, using the reflective cycle by Gibbs. The first stage, preparing the soil, used community engagement, drew on lived experience, encouraged critical self-reflection, embodied reciprocity, and demanded working collectively. The second stage, planting the seed, requires more critical self-reflection, the development of community data through interviews and focus group discussions, the development of resources with an academic working group and community participants, the implementation of those resources with student feedback, the analysis of the feedback from students and community members, and reflection. Results: The protocol for the first stage, preparing the soil, is complete. The results of the first stage are the relationships built and the trust earned and gained, and it has resulted in the development of the planting the seed protocol. As of February 2023, we have recruited 24 participants. We will analyze data shortly and expect to publish the results in 2024. Conclusions: The readiness of non-Indigenous staff to engage with Indigenous communities has not been ascertained by Universities Australia, nor can it be assured. Staff preparation and skills to support the curriculum, create a safe learning environment, and develop teaching and learning strategies to guide academics to recognize that how students learn is as important as the content students learn. This learning has broad implications and benefits for staff and students within their professional practice and for lifelong learning. International Registered Report Identifier (IRRID): DERR1-10.2196/39864 UR - https://www.researchprotocols.org/2023/1/e39864 UR - http://dx.doi.org/10.2196/39864 UR - http://www.ncbi.nlm.nih.gov/pubmed/37200069 ID - info:doi/10.2196/39864 ER - TY - JOUR AU - Grinsztejn, Beatriz AU - Torres, Silva Thiago AU - Hoagland, Brenda AU - Jalil, Moreira Emilia AU - Moreira, Ismerio Ronaldo AU - O'Malley, Gabrielle AU - Shade, B. Starley AU - Benedetti, R. Marcos AU - Moreira, Julio AU - Simpson, Keila AU - Pimenta, Cristina Maria AU - Veloso, Gonçalves Valdiléa AU - PY - 2023/4/19 TI - Long-Acting Injectable Cabotegravir for HIV Preexposure Prophylaxis Among Sexual and Gender Minorities: Protocol for an Implementation Study JO - JMIR Public Health Surveill SP - e44961 VL - 9 KW - sexual and gender minorities KW - young KW - Brazil KW - HIV prevention KW - injectable preexposure prophylaxis KW - injectable PrEP KW - cabotegravir N2 - Background: Long-acting injectable cabotegravir (CAB-LA) for preexposure prophylaxis (PrEP) has proven efficacious in randomized controlled trials. Further research is critical to evaluate its effectiveness in real-world settings and identify effective implementation approaches, especially among young sexual and gender minorities (SGMs). Objective: ImPrEP CAB Brasil is an implementation study aiming to generate critical evidence on the feasibility, acceptability, and effectiveness of incorporating CAB-LA into the existing public health oral PrEP services in 6 Brazilian cities. It will also evaluate a mobile health (mHealth) education and decision support tool, digital injection appointment reminders, and the facilitators of and barriers to integrating CAB-LA into the existing services. Methods: This type-2 hybrid implementation-effectiveness study includes formative work, qualitative assessments, and clinical steps 1 to 4. For formative work, we will use participatory design methods to develop an initial CAB-LA implementation package and process mapping at each site to facilitate optimal client flow. SGMs aged 18 to 30 years arriving at a study clinic interested in PrEP (naive) will be invited for step 1. Individuals who tested HIV negative will receive mHealth intervention and standard of care (SOC) counseling or SOC for PrEP choice (oral or CAB-LA). Participants interested in CAB-LA will be invited for step 2, and those with undetectable HIV viral load will receive same-day CAB-LA injection and will be randomized to receive digital appointment reminders or SOC. Clinical appointments and CAB-LA injection are scheduled after 1 month and every 2 months thereafter (25-month follow-up). Participants will be invited to a 1-year follow-up to step 3 if they decide to change to oral PrEP or discontinue CAB-LA and to step 4 if diagnosed with HIV during the study. Outcomes of interest include PrEP acceptability, choice, effectiveness, implementation, and feasibility. HIV incidence in the CAB-LA cohort (n=1200) will be compared with that in a similar oral PrEP cohort from the public health system. The effectiveness of the mHealth and digital interventions will be assessed using interrupted time series analysis and logistic mixed models, respectively. Results: During the third and fourth quarters of 2022, we obtained regulatory approvals; programmed data entry and management systems; trained sites; and performed community consultancy and formative work. Study enrollment is programmed for the second quarter of 2023. Conclusions: ImPrEP CAB Brasil is the first study to evaluate CAB-LA PrEP implementation in Latin America, one of the regions where PrEP scale-up is most needed. This study will be fundamental to designing programmatic strategies for implementing and scaling up feasible, equitable, cost-effective, sustainable, and comprehensive alternatives for PrEP programs. It will also contribute to maximizing the impact of a public health approach to reducing HIV incidence among SGMs in Brazil and other countries in the Global South. Trial Registration: Clinicaltrials.gov NCT05515770; https://clinicaltrials.gov/ct2/show/NCT05515770 International Registered Report Identifier (IRRID): PRR1-10.2196/44961 UR - https://publichealth.jmir.org/2023/1/e44961 UR - http://dx.doi.org/10.2196/44961 UR - http://www.ncbi.nlm.nih.gov/pubmed/37074775 ID - info:doi/10.2196/44961 ER - TY - JOUR AU - Sullivan, Sean Patrick AU - Hall, Eric AU - Bradley, Heather AU - Sanchez, Travis AU - Woodyatt, R. Cory AU - Russell, S. Elizabeth PY - 2023/3/7 TI - Estimating HIV Incident Diagnoses Among Men Who Have Sex With Men Eligible for Pre-exposure Prophylaxis but Not Taking It: Protocol and Feasibility Assessment of Data Sources and Methods JO - JMIR Res Protoc SP - e42267 VL - 12 KW - HIV incidence estimates KW - pre-exposure prophylaxis KW - commercial pharmacy data KW - HIV KW - HIV epidemic KW - surveillance data KW - public health KW - men who have sex with men KW - health monitoring KW - clinical trial design N2 - Background: HIV incidence estimates are published each year for all Ending the HIV Epidemic (EHE) counties, but they are not stratified by the demographic variables highly associated with risk of infection. Regularly updated estimates of HIV incident diagnoses available at local levels are required to monitor the epidemic in the United States over time and could contribute to background incidence rate estimates for alternative clinical trial designs for new HIV prevention products. Objective: We describe methods using existing, robust data sources within areas in the United States to reliably estimate longitudinal HIV incident diagnoses stratified by race and age categories among men who have sex with other men (MSM) eligible for pre-exposure prophylaxis (PrEP) but not taking it. Methods: This is a secondary analysis of existing data sources to develop new estimates of incident HIV diagnoses in MSM. We reviewed past methods used to estimate incident diagnoses and explored opportunities to improve these estimates. We will use existing surveillance data sources and population sizes of HIV PrEP-eligible MSM estimated from population-based data sources (eg, US Census data and pharmaceutical prescription databases) to develop metropolitan statistical area?level estimates of new HIV diagnoses among PrEP-eligible MSM. Required parameters are number of new diagnoses among MSM, estimates of MSM with an indication for PrEP, and prevalent PrEP use including median duration of use; these parameters will be stratified by jurisdiction and age group or race or ethnicity. Preliminary outputs will be available in 2023, and updated estimates will be produced annually thereafter. Results: Data to parameterize new HIV diagnoses among PrEP-eligible MSM are available with varying levels of public availability and timeliness. In early 2023, the most recent available data on new HIV diagnoses were from the 2020 HIV surveillance report, which reports 30,689 new HIV infections in 2020, and 24,724 of them occurred in an MSA with a population of ?500,000. Updated estimates for PrEP coverage based on commercial pharmacy claims data through February 2023 will be generated. The rate of new HIV diagnoses among MSM can be estimated from new diagnoses within each demographic group (numerator) and the total person-time at risk of diagnosis for each group (denominator) by metropolitan statistical area and year. To estimate time at risk, the person-time of individuals on PrEP or person-time after incident HIV infection but before diagnosis should be removed from stratified population size estimates of the total number of person-years with indications for PrEP. Conclusions: Reliable, serial, cross-sectional estimates for rates of new HIV diagnoses for MSM with PrEP indications can serve as benchmark community estimates of failures of HIV prevention and opportunities to improve services and will support public health epidemic monitoring and alternative clinical trial designs. International Registered Report Identifier (IRRID): DERR1-10.2196/42267 UR - https://www.researchprotocols.org/2023/1/e42267 UR - http://dx.doi.org/10.2196/42267 UR - http://www.ncbi.nlm.nih.gov/pubmed/36881450 ID - info:doi/10.2196/42267 ER - TY - JOUR AU - Mayor, Nikhil AU - Meza-Torres, Bernardo AU - Okusi, Cecilia AU - Delanerolle, Gayathri AU - Chapman, Martin AU - Wang, Wenjuan AU - Anand, Sneha AU - Feher, Michael AU - Macartney, Jack AU - Byford, Rachel AU - Joy, Mark AU - Gatenby, Piers AU - Curcin, Vasa AU - Greenhalgh, Trisha AU - Delaney, Brendan AU - de Lusignan, Simon PY - 2022/8/11 TI - Developing a Long COVID Phenotype for Postacute COVID-19 in a National Primary Care Sentinel Cohort: Observational Retrospective Database Analysis JO - JMIR Public Health Surveill SP - e36989 VL - 8 IS - 8 KW - medical record systems KW - computerized KW - Systematized Nomenclature of Medicine KW - postacute COVID-19 syndrome KW - phenotype KW - COVID-19 KW - long COVID KW - ethnicity KW - social class KW - general practitioners KW - data accuracy KW - data extracts KW - biomedical ontologies KW - SARS-CoV-2 KW - hospitalization KW - epidemiology KW - surveillance KW - public health KW - BioPortal KW - electronic health record KW - disease management KW - digital tool N2 - Background: Following COVID-19, up to 40% of people have ongoing health problems, referred to as postacute COVID-19 or long COVID (LC). LC varies from a single persisting symptom to a complex multisystem disease. Research has flagged that this condition is underrecorded in primary care records, and seeks to better define its clinical characteristics and management. Phenotypes provide a standard method for case definition and identification from routine data and are usually machine-processable. An LC phenotype can underpin research into this condition. Objective: This study aims to develop a phenotype for LC to inform the epidemiology and future research into this condition. We compared clinical symptoms in people with LC before and after their index infection, recorded from March 1, 2020, to April 1, 2021. We also compared people recorded as having acute infection with those with LC who were hospitalized and those who were not. Methods: We used data from the Primary Care Sentinel Cohort (PCSC) of the Oxford Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) database. This network was recruited to be nationally representative of the English population. We developed an LC phenotype using our established 3-step ontological method: (1) ontological step (defining the reasoning process underpinning the phenotype, (2) coding step (exploring what clinical terms are available, and (3) logical extract model (testing performance). We created a version of this phenotype using Protégé in the ontology web language for BioPortal and using PhenoFlow. Next, we used the phenotype to compare people with LC (1) with regard to their symptoms in the year prior to acquiring COVID-19 and (2) with people with acute COVID-19. We also compared hospitalized people with LC with those not hospitalized. We compared sociodemographic details, comorbidities, and Office of National Statistics?defined LC symptoms between groups. We used descriptive statistics and logistic regression. Results: The long-COVID phenotype differentiated people hospitalized with LC from people who were not and where no index infection was identified. The PCSC (N=7.4 million) includes 428,479 patients with acute COVID-19 diagnosis confirmed by a laboratory test and 10,772 patients with clinically diagnosed COVID-19. A total of 7471 (1.74%, 95% CI 1.70-1.78) people were coded as having LC, 1009 (13.5%, 95% CI 12.7-14.3) had a hospital admission related to acute COVID-19, and 6462 (86.5%, 95% CI 85.7-87.3) were not hospitalized, of whom 2728 (42.2%) had no COVID-19 index date recorded. In addition, 1009 (13.5%, 95% CI 12.73-14.28) people with LC were hospitalized compared to 17,993 (4.5%, 95% CI 4.48-4.61; P<.001) with uncomplicated COVID-19. Conclusions: Our LC phenotype enables the identification of individuals with the condition in routine data sets, facilitating their comparison with unaffected people through retrospective research. This phenotype and study protocol to explore its face validity contributes to a better understanding of LC. UR - https://publichealth.jmir.org/2022/8/e36989 UR - http://dx.doi.org/10.2196/36989 UR - http://www.ncbi.nlm.nih.gov/pubmed/35861678 ID - info:doi/10.2196/36989 ER - TY - JOUR AU - Liu, Jia PY - 2022/6/13 TI - HIV Digital Vaccine Strategy: Proposal for Applying Blockchain in Preventing the Spread of HIV JO - JMIR Res Protoc SP - e37133 VL - 11 IS - 6 KW - HIV KW - blockchain KW - digital vaccine KW - decentralized surveillance N2 - Background: The HIV epidemic imposes a heavy burden on societal development. Protection of susceptible populations is the most feasible method for eliminating the spread of HIV. In the absence of a biological vaccine, the definitive solution is enabling susceptible populations to recognize and avoid high-risk sexual behavior. Objective: The objective of this study is to use specific technologies and strategies to establish a system by which high-HIV-risk individuals can determine the HIV infection status of one another anonymously, conveniently, and credibly. Methods: This study proposes an HIV digital vaccine (HDV) strategy, a decentralized application (Dapp) based on blockchain for use by individuals with a high risk of HIV and accredited testing agencies (ATAs). Following testing, only the HIV-negative results (or linked information) are uploaded to the blockchain, which results in high-risk individuals being able to determine the HIV-negative status of each other anonymously, conveniently, and credibly. Results: Future work includes the following: (1) a survey of the willingness to use Dapps among high-HIV-risk populations, (2) a larger framework containing both HDV and people living with HIV (PLH) and discussing the influence of HDV on PLH and its possible solutions, and (3) coordinating with the blockchain development team, ATAs, community-based organizations, and third-party organizations to raise funds, develop the Dapp, formulate detailed plans, and publicize and promote it. The exact timeline for achieving these objectives cannot be determined at present. Conclusions: The HDV strategy may reduce the occurrence of high-risk sexual behavior and effectively protect susceptible populations; combined with current strategies, it is a promising solution to prevent the spread of HIV. The included concepts of decentralized surveillance and surveillance as intervention may spark a change in current infectious disease prevention and control modes to introduce beneficial innovations in public health systems globally. International Registered Report Identifier (IRRID): PRR1-10.2196/37133 UR - https://www.researchprotocols.org/2022/6/e37133 UR - http://dx.doi.org/10.2196/37133 UR - http://www.ncbi.nlm.nih.gov/pubmed/35700007 ID - info:doi/10.2196/37133 ER - TY - JOUR AU - Wirtz, L. Andrea AU - Page, R. Kathleen AU - Stevenson, Megan AU - Guillén, Rafael José AU - Ortíz, Jennifer AU - López, Jairo Jhon AU - Ramírez, Fredy Jhon AU - Quijano, Cindy AU - Vela, Alejandra AU - Moreno, Yessenia AU - Rigual, Francisco AU - Case, James AU - Hakim, J. Avi AU - Hladik, Wolfgang AU - Spiegel, B. Paul PY - 2022/3/8 TI - HIV Surveillance and Research for Migrant Populations: Protocol Integrating Respondent-Driven Sampling, Case Finding, and Medicolegal Services for Venezuelans Living in Colombia JO - JMIR Res Protoc SP - e36026 VL - 11 IS - 3 KW - HIV KW - epidemiology KW - migrant KW - Venezuela KW - Colombia KW - respondent-driven sampling KW - case finding KW - HIV treatment KW - HIV surveillance KW - research N2 - Background: Epidemiologic research among migrant populations is limited by logistical, methodological, and ethical challenges, but it is necessary for informing public health and humanitarian programming. Objective: We describe a methodology to estimate HIV prevalence among Venezuelan migrants in Colombia. Methods: Respondent-driven sampling, a nonprobability sampling method, was selected for attributes of reaching highly networked populations without sampling frames and analytic methods that permit estimation of population parameters. Respondent-driven sampling was modified to permit electronic referral of peers via SMS text messaging and WhatsApp. Participants complete sociobehavioral surveys and rapid HIV and syphilis screening tests with confirmatory testing. HIV treatment is not available for migrants who have entered Colombia through irregular pathways; thus, medicolegal services integrated into posttest counseling provide staff lawyers and legal assistance to participants diagnosed with HIV or syphilis for sustained access to treatment through the national health system. Case finding is integrated into respondent-driven sampling to allow partner referral. This study is implemented by a local community-based organization providing HIV support services and related legal services for Venezuelans in Colombia. Results: Data collection was launched in 4 cities in July and August 2021. As of November 2021, 3105 of the target 6100 participants were enrolled, with enrollment expected to end by February/March 2022. Conclusions: Tailored methods that combine community-led efforts with innovations in sampling and linkage to care can aid in advancing health research for migrant and displaced populations. Worldwide trends in displacement and migration underscore the value of improved methods for translation to humanitarian and public health programming. International Registered Report Identifier (IRRID): DERR1-10.2196/36026 UR - https://www.researchprotocols.org/2022/3/e36026 UR - http://dx.doi.org/10.2196/36026 UR - http://www.ncbi.nlm.nih.gov/pubmed/35258458 ID - info:doi/10.2196/36026 ER - TY - JOUR AU - Donaldson, L. Anna AU - Harris, P. John AU - Vivancos, Roberto AU - Hungerford, Daniel AU - Hall, Ian AU - O'Brien, J. Sarah PY - 2022/1/20 TI - School Attendance Registers for the Syndromic Surveillance of Infectious Intestinal Disease in UK Children: Protocol for a Retrospective Analysis JO - JMIR Res Protoc SP - e30078 VL - 11 IS - 1 KW - syndromic surveillance KW - schools KW - children KW - absenteeism KW - infectious intestinal disease KW - diarrhea and vomiting KW - school attendance registers N2 - Background: Infectious intestinal disease (IID) is common, and children are more likely than adults both to have IID and to transmit infection onto others. Before the introduction of the vaccine, rotavirus was the leading cause of severe childhood diarrhea, with norovirus and Campylobacter predominate pathogens. Public health surveillance of IID is primarily based on health care data, and as such, illness that is managed within the community will often go undetected. School attendance registers offer a novel data set that has the potential to identify community cases and outbreaks of IID that would otherwise be missed by current health surveillance systems. Although studies have explored the role of school attendance registers in the monitoring of influenza among children, no studies have been identified that consider this approach in the surveillance of IID. Objective: The aim of this study is to explore the role and utility of school attendance registers in the detection and surveillance of IID in children. The secondary aims are to estimate the burden of IID on school absenteeism and to assess the impact of the rotavirus vaccine on illness absence among school-aged children. Methods: This study is a retrospective analysis of school attendance registers to investigate whether school absences due to illness can be used to capture seasonal trends and outbreaks of infectious intestinal disease among school-aged children. School absences in Merseyside, United Kingdom will be compared and combined with routine health surveillance data from primary care, laboratories, and telehealth services. These data will be used to model spatial and temporal variations in the incidence of IID and to apportion likely causes to changes in school absenteeism trends. This will be used to assess the potential utility of school attendance data in the surveillance of IID and to estimate the burden of IID absenteeism in schools. It will also inform an analysis of the impact of the rotavirus vaccine on disease within this age group. Results: This study has received ethical approval from the University of Liverpool Research Ethics Committee (reference number 1819). Use of general practice data has been approved for the evaluation of rotavirus vaccination in Merseyside by NHS Research Ethics Committee, South Central-Berkshire REC Reference 14/SC/1140. Conclusions: This study is unique in considering whether school attendance registers could be used to enhance the surveillance of IID. Such data have multiple potential applications and could improve the identification of outbreaks within schools, allowing early intervention to reduce transmission both within and outside of school settings. These data have the potential to act as an early warning system, identifying infections circulating within the community before they enter health care settings. School attendance data could also inform the evaluation of vaccination programs, such as rotavirus and, in time, norovirus. International Registered Report Identifier (IRRID): DERR1-10.2196/30078 UR - https://www.researchprotocols.org/2022/1/e30078 UR - http://dx.doi.org/10.2196/30078 UR - http://www.ncbi.nlm.nih.gov/pubmed/35049509 ID - info:doi/10.2196/30078 ER - TY - JOUR AU - Melvin, Lee Cathy AU - Sterba, Regan Katherine AU - Gimbel, Ron AU - Lenert, Andrew Leslie AU - Cartmell, B. Kathleen AU - PY - 2022/1/19 TI - Dissemination and Implementation of a Google Apple Exposure Notification System for COVID-19 Risk Mitigation at a National Public University: Protocol for a Pilot Evaluation Study in a Real-World Setting JO - JMIR Res Protoc SP - e32567 VL - 11 IS - 1 KW - COVID-19 KW - risk KW - mitigation KW - mobile phone technology KW - exposure notification system KW - university setting KW - implementation science KW - implementation KW - dissemination KW - notification KW - university KW - exposure KW - transmission KW - communication KW - strategy KW - outcome KW - acceptability KW - adoption KW - usage N2 - Background: As SARS-CoV-2, the virus that causes COVID-19, spread rapidly across the United States in the spring of 2020, institutions of higher education faced numerous challenges associated with minimizing risk of exposure to COVID-19 among their students, faculty, staff, and surrounding communities. This paper describes the protocol, South Carolina (SC) Safer Together, developed by Clemson University (Clemson) to design, deploy, and evaluate multi-level communication and dissemination and implementation (D&I) strategies in line with recommendations from governmental and educational agencies to mitigate the risk of exposure to COVID-19. Safer Together was enhanced by the addition of the Google/Apple Exposure Notification app, an alternative strategy to support a recommendation of COVID-19 testing outcomes: contact tracing, isolation, and quarantine. Objective: This study aimed to (1) describe the content and intended audiences of D&I strategies used to deploy recommended COVID-19 mitigation strategies on a major college campus; (2) determine the reach, acceptability, adoption, and use of D&I strategies among target audiences among university students, faculty, and staff; and (3) characterize barriers and facilitators to the implementation and use of recommended mitigation strategies. Methods: The study team incorporated elements of the Health Belief Model, the Technology Acceptance Model, communication and social marketing models, and the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework to identify and develop appropriate constructs and specific outcomes for inclusion in our approach to evaluate the communication, dissemination and implementation processes related to deployment of Safer Together at Clemson. A parallel convergent mixed methods design was used to (1) inform implementation strategies used to launch the program and (2) evaluate program reach, acceptability, adoption, and use guided by the RE-AIM framework. Data collection tools include surveys, data analytics?tracking, and focus groups or interviews with key stakeholders (students, employees, and university leadership). Results: Rigorously studying both the dissemination and implementation of Safer Together in a national public university setting is expected to yield lessons that will be valuable at many organizational and governmental settings. On a local level, broad adoption and use of the Safer Together may help reduce COVID-19 transmission and keep the university ?open.? On a larger scale, lessons learned on how to influence student and employee behavior with respect to the use of a public health outbreak prevention tool including Safer Together may be applicable in future pandemic and outbreak situations. Conclusions: This study proposes a structured, theory-driven approach to evaluate dissemination and implementation strategies associated with the deployment of Safer Together in a university setting from the viewpoint of students, employees, and university leadership. Our results will inform future implementation of apps such as Safer Together at major state universities in SC. International Registered Report Identifier (IRRID): DERR1-10.2196/32567 UR - https://www.researchprotocols.org/2022/1/e32567 UR - http://dx.doi.org/10.2196/32567 UR - http://www.ncbi.nlm.nih.gov/pubmed/34978533 ID - info:doi/10.2196/32567 ER - TY - JOUR AU - Horvath, Correia Jaqueline Driemeyer AU - Bessel, Marina AU - Kops, Luiza Natália AU - Souza, Alves Flávia Moreno AU - Pereira, Mendes Gerson AU - Wendland, Marcia Eliana PY - 2022/1/5 TI - A Nationwide Evaluation of the Prevalence of Human Papillomavirus in Brazil (POP-Brazil Study): Protocol for Data Quality Assurance and Control JO - JMIR Res Protoc SP - e31365 VL - 11 IS - 1 KW - quality control KW - quality assurance KW - evidence-based medicine KW - quality data N2 - Background: The credibility of a study and its internal and external validity depend crucially on the quality of the data produced. An in-depth knowledge of quality control processes is essential as large and integrative epidemiological studies are increasingly prioritized. Objective: This study aimed to describe the stages of quality control in the POP-Brazil study and to present an analysis of the quality indicators. Methods: Quality assurance and control were initiated with the planning of this nationwide, multicentric study and continued through the development of the project. All quality control protocol strategies, such as training, protocol implementation, audits, and inspection, were discussed one by one. We highlight the importance of conducting a pilot study that provides the researcher the opportunity to refine or modify the research methodology and validating the results through double data entry, test-retest, and analysis of nonresponse rates. Results: This cross-sectional, nationwide, multicentric study recruited 8628 sexually active young adults (16-25 years old) in 119 public health units between September 2016 and November 2017. The Human Research Ethics Committee of the Moinhos de Vento Hospital approved this project. Conclusions: Quality control processes are a continuum, not restricted to a single event, and are fundamental to the success of data integrity and the minimization of bias in epidemiological studies. The quality control steps described can be used as a guide to implement evidence-based, valid, reliable, and useful procedures in most observational studies to ensure data integrity. International Registered Report Identifier (IRRID): RR1-10.2196/31365 UR - https://www.researchprotocols.org/2022/1/e31365 UR - http://dx.doi.org/10.2196/31365 UR - http://www.ncbi.nlm.nih.gov/pubmed/34989680 ID - info:doi/10.2196/31365 ER - TY - JOUR AU - Wasfi, Rania AU - Poirier Stephens, Zoe AU - Sones, Meridith AU - Laberee, Karen AU - Pugh, Caitlin AU - Fuller, Daniel AU - Winters, Meghan AU - Kestens, Yan PY - 2021/11/12 TI - Recruiting Participants for Population Health Intervention Research: Effectiveness and Costs of Recruitment Methods for a Cohort Study JO - J Med Internet Res SP - e21142 VL - 23 IS - 11 KW - recruitment methods KW - Facebook recruitment KW - cost-effectiveness KW - built environment KW - intervention research KW - natural experiment KW - mobile phone N2 - Background: Public health research studies often rely on population-based participation and draw on various recruitment methods to establish samples. Increasingly, researchers are turning to web-based recruitment tools. However, few studies detail traditional and web-based recruitment efforts in terms of costs and potential biases. Objective: This study aims to report on and evaluate the cost-effectiveness, time effectiveness, and sociodemographic representation of diverse recruitment methods used to enroll participants in 3 cities of the Interventions, Research, and Action in Cities Team (INTERACT) study, a cohort study conducted in Canadian cities. Methods: Over 2017 and 2018 in Vancouver, Saskatoon, and Montreal, the INTERACT study used the following recruitment methods: mailed letters, social media (including sponsored Facebook advertisements), news media, partner communications, snowball recruitment, in-person recruitment, and posters. Participation in the study involved answering web-based questionnaires (at minimum), activating a smartphone app to share sensor data, and wearing a device for mobility and physical activity monitoring. We describe sociodemographic characteristics by the recruitment method and analyze performance indicators, including cost, completion rate, and time effectiveness. Effectiveness included calculating cost per completer (ie, a participant who completed at least one questionnaire), the completion rate of a health questionnaire, and the delay between completion of eligibility and health questionnaires. Cost included producing materials (ie, printing costs), transmitting recruitment messages (ie, mailing list rental, postage, and sponsored Facebook posts charges), and staff time. In Montreal, the largest INTERACT sample, we modeled the number of daily recruits through generalized linear models accounting for the distributed lagged effects of recruitment campaigns. Results: Overall, 1791 participants were recruited from 3 cities and completed at least one questionnaire: 318 in Vancouver, 315 in Saskatoon, and 1158 in Montreal. In all cities, most participants chose to participate fully (questionnaires, apps, and devices). The costs associated with a completed participant varied across recruitment methods and by city. Facebook advertisements generated the most recruits (n=687), at a cost of CAD $15.04 (US $11.57; including staff time) per completer. Mailed letters were the costliest, at CAD $108.30 (US $83.3) per completer but served to reach older participants. All methods resulted in a gender imbalance, with women participating more, specifically with social media. Partner newsletters resulted in the participation of younger adults and were cost-efficient (CAD $5.16 [US $3.97] per completer). A generalized linear model for daily Montreal recruitment identified 2-day lag effects on most recruitment methods, except for the snowball campaign (4 days), letters (15 days), and reminder cards (5 days). Conclusions: This study presents comprehensive data on the costs, effectiveness, and bias of population recruitment in a cohort study in 3 Canadian cities. More comprehensive documentation and reporting of recruitment efforts across studies are needed to improve our capacity to conduct inclusive intervention research. UR - https://www.jmir.org/2021/11/e21142 UR - http://dx.doi.org/10.2196/21142 UR - http://www.ncbi.nlm.nih.gov/pubmed/34587586 ID - info:doi/10.2196/21142 ER - TY - JOUR AU - Menon, Jaideep AU - Numpeli, Mathews AU - Kunjan, P. Sajeev AU - Karimbuvayilil, V. Beena AU - Sreedevi, Aswathy AU - Panniyamakkal, Jeemon AU - Suseela, P. Rakesh AU - Thachathodiyil, Rajesh AU - Banerjee, Amitava PY - 2021/10/22 TI - A Sustainable Community-Based Model of Noncommunicable Disease Risk Factor Surveillance (Shraddha-Jagrithi Project): Protocol for a Cohort Study JO - JMIR Res Protoc SP - e27299 VL - 10 IS - 10 KW - non-communicable diseases KW - surveillance KW - accredited social health activist KW - panchayat (village) KW - primary health centre KW - spoke and hub KW - cardiovascular KW - public health KW - hypertension KW - health services KW - health center KW - diabetes N2 - Background: India has a massive noncommunicable disease (NCD) burden, at an enormous cost to the individual, family, society, and health system at large, despite which prevention and surveillance are relatively neglected. If diagnosed early and treated adequately, risk factors for atherosclerotic cardiovascular disease would help decrease the mortality and morbidity burden. Surveillance for NCDs, creating awareness, positive lifestyle changes, and treatment are the proven measures known to prevent the progression of the disease. India is in a stage of rapid epidemiological transition, with the state of Kerala being at the forefront, pointing us towards likely disease burden and outcomes for the rest of the country in the future. A previous study done by the same investigators in a population of >100,000 revealed poor awareness, treatment of NCDs, and poor adherence to medicines in individuals with CVD. Objective: This study aimed at assessing a sustainable, community-based surveillance model for NCDs with corporate support fully embedded in the public health system. Methods: Frontline health workers will check all individuals in the target group (?age 30 years) with further follow-up and treatment planned in a ?spoke and hub? model using the public health system of primary health centers as spokes to the hubs of taluk or district hospitals. All data entry done by frontline health workers will be on a tablet PC, ensuring rapid acquisition and transfer of participant health details to primary health centers for further follow-up and treatment. Results: The model will be evaluated based on the utilization rate of various services offered at all tier levels. The proportions of the target population screened, eligible individuals who reached the spoke or hub centers for risk stratification and care, and community-level control for hypertension and diabetes in annual surveys will be used as indicator variables. The model ensures diagnosis and follow-up treatment at no cost to the individual entirely through the tiered public health system of the state and country. Conclusions: Surveillance for NCDs is an essential facet of health care presently lacking in India. Atherosclerotic cardiovascular disease has a long gestation period in progression to the symptomatic phase of the disease, during which timely preventive and lifestyle measures would help prevent disease progression if implemented. Unfortunately, several asymptomatic individuals have never tested their plasma glucose, serum lipid levels, or blood pressure and are unaware of their disease status. Our model, implemented through the public health system using frontline health workers, would ensure individuals aged?30 years at risk of disease are identified, and necessary lifestyle modifications and treatments are given. In addition, the surveillance at the community level would help create a general awareness of NCDs and lead to healthier lifestyle habits. Trial Registration: Clinical Trial Registry India CTRI/2018/07/014856; https://tinyurl.com/4saydnxf International Registered Report Identifier (IRRID): DERR1-10.2196/27299 UR - https://www.researchprotocols.org/2021/10/e27299 UR - http://dx.doi.org/10.2196/27299 UR - http://www.ncbi.nlm.nih.gov/pubmed/34677141 ID - info:doi/10.2196/27299 ER - TY - JOUR AU - Frew, M. Paula AU - Randall, A. Laura AU - King, R. Adrian AU - Schamel, T. Jay AU - Spaulding, C. Anne AU - AU - Holloway, W. Ian PY - 2021/9/10 TI - Health Behavior Survey Among People Who Use Opioids: Protocol for Implementing Technology-Based Rapid Response Surveillance in Community Settings JO - JMIR Res Protoc SP - e25575 VL - 10 IS - 9 KW - substance use KW - opioid KW - opioid crisis KW - social determinants KW - hidden populations KW - health equity N2 - Background: In 2018, 2 million Americans met the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition diagnostic criteria for an opioid use disorder, and 9.9 million Americans had misused prescription pain relievers the previous year. Despite a rapid increase in opioid misuse, opioid use disorders, and overdoses, data are limited on the behavioral and contextual risks as well as the protective factors fueling the opioid epidemic in some hard hit US cities?Atlanta, Los Angeles, and Las Vegas. Opioid use also contributes to the risk of other health problems such as HIV and hepatitis C virus infections or mental health disorders and is linked to behavioral and environmental risks (eg, homelessness, experiences of violence, involvement in the justice system). Knowledge of the relationships between these linked vulnerabilities and how they influence service utilization is critical to effective policy and interventions. Objective: This survey explores the relationships between demographic and economic characteristics, behavioral and environmental risk factors, and service utilization of people who use opioids to inform public health practice, policy, and future efforts to mitigate the risks faced by this population experiencing multiple health, social, and economic vulnerabilities. The results of this survey will be used to identify needs and intervention points for people who use drugs currently served by public health organizations. Methods: We implemented a community-engaged strategy that involved development and execution of a two-stage purposive sampling plan involving selection of partner organizations (syringe exchange programs in urban settings) and recruitment and enrollment of participants aged 18-69 years served by these organizations in Atlanta, Los Angeles, and Las Vegas from 2019 to 2020. The recruited participants completed a survey, including a variety of measures to assess health (physical and mental) and health behaviors such as sexual behavior, vaccine receipt, and HIV/ hepatitis C virus infection testing. Additional items assessed drug use and misuse, syringe exchange and health service utilization, sex exchange, histories of interpersonal violence, and vaccine confidence. Results: This protocol was successfully implemented despite challenges such as real-time technology issues and rapidly finding and surveying a difficult-to-reach population. We sampled 1127 unique participants (248 in Atlanta, 465 in Los Angeles, and 414 in Las Vegas). Conclusions: The establishment and utilization of strong community partnerships enabled the rapid collection of data from a typically difficult-to-reach population. Local efforts such as these are needed to develop policies and practices that promote harm reduction among people who use opioids. International Registered Report Identifier (IRRID): RR1-10.2196/25575 UR - https://www.researchprotocols.org/2021/9/e25575 UR - http://dx.doi.org/10.2196/25575 UR - http://www.ncbi.nlm.nih.gov/pubmed/34505834 ID - info:doi/10.2196/25575 ER - TY - JOUR AU - Lambraki, Anna Irene AU - Majowicz, Elizabeth Shannon AU - Parmley, Jane Elizabeth AU - Wernli, Didier AU - Léger, Anaïs AU - Graells, Tiscar AU - Cousins, Melanie AU - Harbarth, Stephan AU - Carson, Carolee AU - Henriksson, Patrik AU - Troell, Max AU - Jørgensen, Søgaard Peter PY - 2021/6/10 TI - Building Social-Ecological System Resilience to Tackle Antimicrobial Resistance Across the One Health Spectrum: Protocol for a Mixed Methods Study JO - JMIR Res Protoc SP - e24378 VL - 10 IS - 6 KW - antimicrobial resistance KW - One Health KW - resilience KW - transdisciplinary KW - participatory KW - interventions KW - systems dynamics KW - social-ecological system N2 - Background: Antimicrobial resistance (AMR) is an escalating global crisis with serious health, social, and economic consequences. Building social-ecological system resilience to reduce AMR and mitigate its impacts is critical. Objective: The aim of this study is to compare and assess interventions that address AMR across the One Health spectrum and determine what actions will help to build social and ecological capacity and readiness to sustainably tackle AMR. Methods: We will apply social-ecological resilience theory to AMR in an explicit One Health context using mixed methods and identify interventions that address AMR and its key pressure antimicrobial use (AMU) identified in the scientific literature and in the gray literature using a web-based survey. Intervention impacts and the factors that challenge or contribute to the success of interventions will be determined, triangulated against expert opinions in participatory workshops and complemented using quantitative time series analyses. We will then identify indicators using regression modeling, which can predict national and regional AMU or AMR dynamics across animal and human health. Together, these analyses will help to quantify the causal loop diagrams (CLDs) of AMR in the European and Southeast Asian food system contexts that are developed by diverse stakeholders in participatory workshops. Then, using these CLDs, the long-term impacts of selected interventions on AMR will be explored under alternate future scenarios via simulation modeling and participatory workshops. A publicly available learning platform housing information about interventions on AMR from a One Health perspective will be developed to help decision makers identify promising interventions for application in their jurisdictions. Results: To date, 669 interventions have been identified in the scientific literature, 891 participants received a survey invitation, and 4 expert feedback and 4 model-building workshops have been conducted. Time series analysis, regression modeling of national and regional indicators of AMR dynamics, and scenario modeling activities are anticipated to be completed by spring 2022. Ethical approval has been obtained from the University of Waterloo?s Office of Research Ethics (ethics numbers 40519 and 41781). Conclusions: This paper provides an example of how to study complex problems such as AMR, which require the integration of knowledge across sectors and disciplines to find sustainable solutions. We anticipate that our study will contribute to a better understanding of what actions to take and in what contexts to ensure long-term success in mitigating AMR and its impact and provide useful tools (eg, CLDs, simulation models, and public databases of compiled interventions) to guide management and policy decisions. International Registered Report Identifier (IRRID): DERR1-10.2196/24378 UR - https://www.researchprotocols.org/2021/6/e24378 UR - http://dx.doi.org/10.2196/24378 UR - http://www.ncbi.nlm.nih.gov/pubmed/34110296 ID - info:doi/10.2196/24378 ER - TY - JOUR AU - Vandormael, Alain AU - Adam, Maya AU - Hachaturyan, Violetta AU - Greuel, Merlin AU - Favaretti, Caterina AU - Gates, Jennifer AU - Baernighausen, Till PY - 2021/5/28 TI - Reactance to Social Authority in Entertainment-Education Media: Protocol for a Web-Based Randomized Controlled Trial JO - JMIR Res Protoc SP - e25343 VL - 10 IS - 5 KW - entertainment-education KW - sugar reduction KW - reactance KW - animated video KW - list experiment N2 - Background: Entertainment-education media can be an effective strategy for influencing health behaviors. To improve entertainment-education effectiveness, we seek to investigate whether the social authority of a person delivering a health message arouses the motivation to reject that message?a phenomenon known as reactance. Objective: In this study, using a short animated video, we aim to measure reactance to a sugar reduction message narrated by a child (low social authority), the child?s mother (equivalent social authority to the target audience), and a family physician (high social authority). The aims of the study are to determine the effect of the narrator?s perceived social authority on reactance to the sugar reduction message, establish the effectiveness of the video in improving behavioral intent to reduce the intake of added sugars, and quantify participants? interest in watching the entertainment-education intervention video. Methods: This is a parallel group, randomized controlled trial comparing an intervention video narrated by a low, equivalent, or high social authority against a content placebo video and a placebo video. Using a web-based recruitment platform, we plan to enroll 4000 participants aged between 18 and 59 years who speak English and reside in the United Kingdom. The primary end points will include measures of the antecedents to reactance (proneness to reactance and threat level of the message), its components (anger and negative cognition), and attitudinal and behavioral intent toward sugar intake. We will measure behavioral intent using list experiments. Participants randomized to the placebo videos will be given a choice to watch one of the sugar-intervention videos at the end of the study to assess participant engagement with the entertainment-education video. Results: The study was approved by the ethics committee of Heidelberg University on March 18, 2020 (S-088/2020). Participant recruitment and data collection were completed in December 2020. The data analysis was completed in April 2021, and the final results are planned to be published by August 2021. Conclusions: In this trial, we will use several randomization procedures, list experimentation methods, and new web-based technologies to investigate the effect of perceived social authority on reactance to a message about reducing sugar intake. Our results will inform the design of future entertainment-education videos for public health promotion needs. Trial Registration: German Clinical Trials Registry DRKS00022340: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00022340. International Registered Report Identifier (IRRID): DERR1-10.2196/25343 UR - https://www.researchprotocols.org/2021/5/e25343 UR - http://dx.doi.org/10.2196/25343 UR - http://www.ncbi.nlm.nih.gov/pubmed/34047702 ID - info:doi/10.2196/25343 ER - TY - JOUR AU - Sweeney-Reed, M. Catherine AU - Wolff, Doreen AU - Niggel, Jakob AU - Kabesch, Michael AU - Apfelbacher, Christian PY - 2021/5/28 TI - Pool Testing as a Strategy for Prevention of SARS-CoV-2 Outbreaks in Schools: Protocol for a Feasibility Study JO - JMIR Res Protoc SP - e28673 VL - 10 IS - 5 KW - SARS-CoV-2 KW - COVID-19 KW - schools KW - pool testing KW - gargle test KW - test strategy KW - monitoring KW - surveillance KW - PCR N2 - Background: School closures are a widely implemented strategy for limiting infection spread in the current COVID-19 pandemic. The negative impact of school closures on children and young people is increasingly apparent, however. Objective: We aim to evaluate the feasibility of an infection monitoring program in schools to enable targeted quarantining to replace school closures. The program is currently being implemented in two model schools in Magdeburg, Germany, within the framework of the Study of Coronavirus Outbreak Prevention in Magdeburg Schools (Studie zur Ausbruchsvermeidung von Corona an Magdeburger Schulen [STACAMA]). Methods: Five pupils per class are pseudorandomly selected twice a week and asked to provide a gargle sample over a 16-week evaluation period. RNA is extracted from each sample individually in a laboratory and pooled according to school class for real-time reverse transcription polymerase chain reaction (rRT-PCR) analysis. Immediate individual sample testing will be carried out in the case of a positive pool test. Individual RNA extraction prior to pooling and application of rRT-PCR result in high test sensitivity. Testing will be performed in strict adherence to data protection standards. All participating pupils will receive a 16-digit study code, which they will be able to use to access their test Results: When the study commenced on December 2, 2020, 520 (52%) pupils and their families or guardians had consented to study participation. The study was suspended after four test rounds due to renewed school closures resulting from rising regional infection incidence. Testing resumed when schools reopened on March 8, 2021, at which time consent to participation was provided for 54% of pupils. We will quantitatively and qualitatively evaluate the logistics and acceptability of the program. Conclusions: The findings from this study should inform the design of infection surveillance programs in schools based on gargle samples and a PCR-based pool testing procedure, enabling the identification of aspects that may require adaptation before large-scale implementation. Our focus on each step of the logistics and on the experiences of families should enable a robust assessment of the feasibility of such an approach. International Registered Report Identifier (IRRID): DERR1-10.2196/28673 UR - https://www.researchprotocols.org/2021/5/e28673 UR - http://dx.doi.org/10.2196/28673 UR - http://www.ncbi.nlm.nih.gov/pubmed/33979297 ID - info:doi/10.2196/28673 ER - TY - JOUR AU - Mitchell, H. Ellen M. AU - Adejumo, Adedeji Olusola AU - Abdur-Razzaq, Hussein AU - Ogbudebe, Chidubem AU - Chukwueme, Nkem AU - Olorunju, Bamidele Samson AU - Gidado, Mustapha PY - 2021/3/15 TI - Hybrid Approach to Estimation of Underreporting of Tuberculosis Case Notification in High-Burden Settings With Weak Surveillance Infrastructure: Design and Implementation of an Inventory Study JO - JMIR Public Health Surveill SP - e22352 VL - 7 IS - 3 KW - tuberculosis KW - notification KW - integrated disease surveillance reporting KW - private sector KW - inventory study KW - public health surveillance KW - epidemiology KW - infectious disease reporting KW - infectious disease notification N2 - Background: The greatest risk of infectious disease undernotification occurs in settings with limited capacity to detect it reliably. World Health Organization guidance on the measurement of misreporting is paradoxical, requiring robust, independent systems to assess surveillance rigor. Methods are needed to estimate undernotification in settings with incomplete, flawed, or weak surveillance systems. This study attempted to design a tuberculosis (TB) inventory study that balanced rigor with feasibility for high-need settings. Objective: This study aims to design a hybrid TB inventory study for contexts without World Health Organization preconditions. We estimated the proportion of TB cases that were not reported to the Ministry of Health in 2015. The study sought to describe TB surveillance coverage and quality at different levels of TB care provision. Finally, we aimed to identify structural-, facility-, and provider-level barriers to notification and reasons for underreporting, nonreporting, and overreporting. Methods: Retrospective partial digitalization of paper-based surveillance and facility records preceded deterministic and probabilistic record linkage; a hybrid of health facilities and laboratory census with a stratified sampling of HFs with no capacity to notify leveraged a priori knowledge. Distinct extrapolation methods were applied to the sampled health facilities to estimate bacteriologically confirmed versus clinical TB. In-depth interviews and focus groups were used to identify causal factors responsible for undernotification and test the acceptability of remedies. Results: The hybrid approach proved viable and instructive. High-specificity verification of paper-based records in the field was efficient and had minimal errors. Limiting extrapolation to clinical cases improved precision. Probabilistic record linkage is computationally intensive, and the choice of software influences estimates. Record absence, decay, and overestimation of the private sector TB treatment behavior threaten validity, meriting mitigation. Data management demands were underestimated. Treatment success was modest in all sectors (R=37.9%?72.0%) and did not align with treatment success reported by the state (6665/8770, 75.99%). One-fifth of TB providers (36/178, 20%) were doubtful that the low volume of patients with TB treated in their facility merited mastery of the extensive TB notification forms and procedures. Conclusions: Subnational inventory studies can be rigorous, relevant, and efficient in countries that need them even in the absence of World Health Organization preconditions, if precautions are taken. The use of triangulation techniques, with minimal recourse to sampling and extrapolation, and the privileging of practical information needs of local decision makers yield reasonable misreporting estimates and viable policy recommendations. UR - https://publichealth.jmir.org/2021/3/e22352 UR - http://dx.doi.org/10.2196/22352 UR - http://www.ncbi.nlm.nih.gov/pubmed/33720030 ID - info:doi/10.2196/22352 ER - TY - JOUR AU - de Lusignan, Simon AU - Lopez Bernal, Jamie AU - Byford, Rachel AU - Amirthalingam, Gayatri AU - Ferreira, Filipa AU - Akinyemi, Oluwafunmi AU - Andrews, Nick AU - Campbell, Helen AU - Dabrera, Gavin AU - Deeks, Alexandra AU - Elliot, J. Alex AU - Krajenbrink, Else AU - Liyanage, Harshana AU - McGagh, Dylan AU - Okusi, Cecilia AU - Parimalanathan, Vaishnavi AU - Ramsay, Mary AU - Smith, Gillian AU - Tripathy, Manasa AU - Williams, John AU - Victor, William AU - Zambon, Maria AU - Howsam, Gary AU - Nicholson, David Brian AU - Tzortziou Brown, Victoria AU - Butler, C. Christopher AU - Joy, Mark AU - Hobbs, Richard F. D. PY - 2021/2/19 TI - Influenza and Respiratory Virus Surveillance, Vaccine Uptake, and Effectiveness at a Time of Cocirculating COVID-19: Protocol for the English Primary Care Sentinel System for 2020-2021 JO - JMIR Public Health Surveill SP - e24341 VL - 7 IS - 2 KW - COVID-19 KW - general practice KW - influenza KW - computerized medical record systems KW - sentinel surveillance KW - coronavirus infections KW - records as topic KW - serology KW - virology N2 - Background: The Oxford?Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) and Public Health England (PHE) are commencing their 54th season of collaboration at a time when SARS-CoV-2 infections are likely to be cocirculating with the usual winter infections. Objective: The aim of this study is to conduct surveillance of influenza and other monitored respiratory conditions and to report on vaccine uptake and effectiveness using nationally representative surveillance data extracted from primary care computerized medical records systems. We also aim to have general practices collect virology and serology specimens and to participate in trials and other interventional research. Methods: The RCGP RSC network comprises over 1700 general practices in England and Wales. We will extract pseudonymized data twice weekly and are migrating to a system of daily extracts. First, we will collect pseudonymized, routine, coded clinical data for the surveillance of monitored and unexpected conditions; data on vaccine exposure and adverse events of interest; and data on approved research study outcomes. Second, we will provide dashboards to give general practices feedback about levels of care and data quality, as compared to other network practices. We will focus on collecting data on influenza-like illness, upper and lower respiratory tract infections, and suspected COVID-19. Third, approximately 300 practices will participate in the 2020-2021 virology and serology surveillance; this will include responsive surveillance and long-term follow-up of previous SARS-CoV-2 infections. Fourth, member practices will be able to recruit volunteer patients to trials, including early interventions to improve COVID-19 outcomes and point-of-care testing. Lastly, the legal basis for our surveillance with PHE is Regulation 3 of the Health Service (Control of Patient Information) Regulations 2002; other studies require appropriate ethical approval. Results: The RCGP RSC network has tripled in size; there were previously 100 virology practices and 500 practices overall in the network and we now have 322 and 1724, respectively. The Oxford?RCGP Clinical Informatics Digital Hub (ORCHID) secure networks enable the daily analysis of the extended network; currently, 1076 practices are uploaded. We are implementing a central swab distribution system for patients self-swabbing at home in addition to in-practice sampling. We have converted all our primary care coding to Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT) coding. Throughout spring and summer 2020, the network has continued to collect specimens in preparation for the winter or for any second wave of COVID-19 cases. We have collected 5404 swabs and detected 623 cases of COVID-19 through extended virological sampling, and 19,341 samples have been collected for serology. This shows our preparedness for the winter season. Conclusions: The COVID-19 pandemic has been associated with a groundswell of general practices joining our network. It has also created a permissive environment in which we have developed the capacity and capability of the national primary care surveillance systems and our unique public health institute, the RCGP and University of Oxford collaboration. UR - http://publichealth.jmir.org/2021/2/e24341/ UR - http://dx.doi.org/10.2196/24341 UR - http://www.ncbi.nlm.nih.gov/pubmed/33605892 ID - info:doi/10.2196/24341 ER - TY - JOUR AU - de Lusignan, Simon AU - Jones, Nicholas AU - Dorward, Jienchi AU - Byford, Rachel AU - Liyanage, Harshana AU - Briggs, John AU - Ferreira, Filipa AU - Akinyemi, Oluwafunmi AU - Amirthalingam, Gayatri AU - Bates, Chris AU - Lopez Bernal, Jamie AU - Dabrera, Gavin AU - Eavis, Alex AU - Elliot, J. Alex AU - Feher, Michael AU - Krajenbrink, Else AU - Hoang, Uy AU - Howsam, Gary AU - Leach, Jonathan AU - Okusi, Cecilia AU - Nicholson, Brian AU - Nieri, Philip AU - Sherlock, Julian AU - Smith, Gillian AU - Thomas, Mark AU - Thomas, Nicholas AU - Tripathy, Manasa AU - Victor, William AU - Williams, John AU - Wood, Ian AU - Zambon, Maria AU - Parry, John AU - O?Hanlon, Shaun AU - Joy, Mark AU - Butler, Chris AU - Marshall, Martin AU - Hobbs, Richard F. D. PY - 2020/7/2 TI - The Oxford Royal College of General Practitioners Clinical Informatics Digital Hub: Protocol to Develop Extended COVID-19 Surveillance and Trial Platforms JO - JMIR Public Health Surveill SP - e19773 VL - 6 IS - 3 KW - primary health care KW - general practice KW - medical record systems, computerized KW - sentinel surveillance KW - public health surveillance KW - clinical trials as a topic KW - adaptive clinical trials KW - severe acute respiratory syndrome coronavirus 2 KW - COVID-19 N2 - Background: Routinely recorded primary care data have been used for many years by sentinel networks for surveillance. More recently, real world data have been used for a wider range of research projects to support rapid, inexpensive clinical trials. Because the partial national lockdown in the United Kingdom due to the coronavirus disease (COVID-19) pandemic has resulted in decreasing community disease incidence, much larger numbers of general practices are needed to deliver effective COVID-19 surveillance and contribute to in-pandemic clinical trials. Objective: The aim of this protocol is to describe the rapid design and development of the Oxford Royal College of General Practitioners Clinical Informatics Digital Hub (ORCHID) and its first two platforms. The Surveillance Platform will provide extended primary care surveillance, while the Trials Platform is a streamlined clinical trials platform that will be integrated into routine primary care practice. Methods: We will apply the FAIR (Findable, Accessible, Interoperable, and Reusable) metadata principles to a new, integrated digital health hub that will extract routinely collected general practice electronic health data for use in clinical trials and provide enhanced communicable disease surveillance. The hub will be findable through membership in Health Data Research UK and European metadata repositories. Accessibility through an online application system will provide access to study-ready data sets or developed custom data sets. Interoperability will be facilitated by fixed linkage to other key sources such as Hospital Episodes Statistics and the Office of National Statistics using pseudonymized data. All semantic descriptors (ie, ontologies) and code used for analysis will be made available to accelerate analyses. We will also make data available using common data models, starting with the US Food and Drug Administration Sentinel and Observational Medical Outcomes Partnership approaches, to facilitate international studies. The Surveillance Platform will provide access to data for health protection and promotion work as authorized through agreements between Oxford, the Royal College of General Practitioners, and Public Health England. All studies using the Trials Platform will go through appropriate ethical and other regulatory approval processes. Results: The hub will be a bottom-up, professionally led network that will provide benefits for member practices, our health service, and the population served. Data will only be used for SQUIRE (surveillance, quality improvement, research, and education) purposes. We have already received positive responses from practices, and the number of practices in the network has doubled to over 1150 since February 2020. COVID-19 surveillance has resulted in tripling of the number of virology sites to 293 (target 300), which has aided the collection of the largest ever weekly total of surveillance swabs in the United Kingdom as well as over 3000 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serology samples. Practices are recruiting to the PRINCIPLE (Platform Randomised trial of INterventions against COVID-19 In older PeopLE) trial, and these participants will be followed up through ORCHID. These initial outputs demonstrate the feasibility of ORCHID to provide an extended national digital health hub. Conclusions: ORCHID will provide equitable and innovative use of big data through a professionally led national primary care network and the application of FAIR principles. The secure data hub will host routinely collected general practice data linked to other key health care repositories for clinical trials and support enhanced in situ surveillance without always requiring large volume data extracts. ORCHID will support rapid data extraction, analysis, and dissemination with the aim of improving future research and development in general practice to positively impact patient care. International Registered Report Identifier (IRRID): DERR1-10.2196/19773 UR - https://publichealth.jmir.org/2020/3/e19773 UR - http://dx.doi.org/10.2196/19773 UR - http://www.ncbi.nlm.nih.gov/pubmed/32484782 ID - info:doi/10.2196/19773 ER - TY - JOUR AU - de Lusignan, Simon AU - Lopez Bernal, Jamie AU - Zambon, Maria AU - Akinyemi, Oluwafunmi AU - Amirthalingam, Gayatri AU - Andrews, Nick AU - Borrow, Ray AU - Byford, Rachel AU - Charlett, André AU - Dabrera, Gavin AU - Ellis, Joanna AU - Elliot, J. Alex AU - Feher, Michael AU - Ferreira, Filipa AU - Krajenbrink, Else AU - Leach, Jonathan AU - Linley, Ezra AU - Liyanage, Harshana AU - Okusi, Cecilia AU - Ramsay, Mary AU - Smith, Gillian AU - Sherlock, Julian AU - Thomas, Nicholas AU - Tripathy, Manasa AU - Williams, John AU - Howsam, Gary AU - Joy, Mark AU - Hobbs, Richard PY - 2020/4/2 TI - Emergence of a Novel Coronavirus (COVID-19): Protocol for Extending Surveillance Used by the Royal College of General Practitioners Research and Surveillance Centre and Public Health England JO - JMIR Public Health Surveill SP - e18606 VL - 6 IS - 2 KW - general practice KW - medical record systems KW - computerized KW - sentinel surveillance KW - coronavirus KW - COVID-19 KW - SARS-CoV-2 KW - surveillance KW - infections KW - pandemic KW - records as topic KW - serology N2 - Background: The Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) and Public Health England (PHE) have successfully worked together on the surveillance of influenza and other infectious diseases for over 50 years, including three previous pandemics. With the emergence of the international outbreak of the coronavirus infection (COVID-19), a UK national approach to containment has been established to test people suspected of exposure to COVID-19. At the same time and separately, the RCGP RSC?s surveillance has been extended to monitor the temporal and geographical distribution of COVID-19 infection in the community as well as assess the effectiveness of the containment strategy. Objectives: The aims of this study are to surveil COVID-19 in both asymptomatic populations and ambulatory cases with respiratory infections, ascertain both the rate and pattern of COVID-19 spread, and assess the effectiveness of the containment policy. Methods: The RCGP RSC, a network of over 500 general practices in England, extract pseudonymized data weekly. This extended surveillance comprises of five components: (1) Recording in medical records of anyone suspected to have or who has been exposed to COVID-19. Computerized medical records suppliers have within a week of request created new codes to support this. (2) Extension of current virological surveillance and testing people with influenza-like illness or lower respiratory tract infections (LRTI)?with the caveat that people suspected to have or who have been exposed to COVID-19 should be referred to the national containment pathway and not seen in primary care. (3) Serology sample collection across all age groups. This will be an extra blood sample taken from people who are attending their general practice for a scheduled blood test. The 100 general practices currently undertaking annual influenza virology surveillance will be involved in the extended virological and serological surveillance. (4) Collecting convalescent serum samples. (5) Data curation. We have the opportunity to escalate the data extraction to twice weekly if needed. Swabs and sera will be analyzed in PHE reference laboratories. Results: General practice clinical system providers have introduced an emergency new set of clinical codes to support COVID-19 surveillance. Additionally, practices participating in current virology surveillance are now taking samples for COVID-19 surveillance from low-risk patients presenting with LRTIs. Within the first 2 weeks of setup of this surveillance, we have identified 3 cases: 1 through the new coding system, the other 2 through the extended virology sampling. Conclusions: We have rapidly converted the established national RCGP RSC influenza surveillance system into one that can test the effectiveness of the COVID-19 containment policy. The extended surveillance has already seen the use of new codes with 3 cases reported. Rapid sharing of this protocol should enable scientific critique and shared learning. International Registered Report Identifier (IRRID): DERR1-10.2196/18606 UR - https://publichealth.jmir.org/2020/2/e18606 UR - http://dx.doi.org/10.2196/18606 UR - http://www.ncbi.nlm.nih.gov/pubmed/32240095 ID - info:doi/10.2196/18606 ER - TY - JOUR AU - Siegler, J. Aaron AU - Rosenthal, M. Elizabeth AU - Sullivan, S. Patrick AU - Ahlschlager, Lauren AU - Kelley, F. Colleen AU - Mehta, Christina C. AU - Moore, H. Reneé AU - Rosenberg, S. Eli AU - Cecil, P. Michael PY - 2019/04/23 TI - Double-Blind, Single-Center, Randomized Three-Way Crossover Trial of Fitted, Thin, and Standard Condoms for Vaginal and Anal Sex: C-PLEASURE Study Protocol and Baseline Data JO - JMIR Res Protoc SP - e12205 VL - 8 IS - 4 KW - condoms KW - HIV prevention KW - sexual health KW - clinical trial N2 - Background: Male condoms are underused despite their ability to prevent transmission of HIV and other sexually transmitted infections. The perception of decreased sexual pleasure and poor condom fit are major contributors to condom nonuse. Objective: The purpose of this study was to compare event-level performance and pleasure using fitted, thin, and standard condoms among men who have sex with men (MSM) and men who have sex with women (MSW). We also sought to assess condom type preference. We present the study design and enrollment data from the trial. Methods: This study recruited sexually active men aged 18 to 54 years in Atlanta, Georgia, United States. We enrolled 252 MSM and 252 MSW in a double-blind, 3-way randomized crossover trial with conditions of fitted, thin, and standard condoms. A permuted block randomization scheme was used to assign each participant to the sequence in which they received each type of study condom. After a baseline screening and enrollment visit, randomized participants were followed for at least 6 and up to 12 weeks depending on their use of study condoms in each 2-week period between scheduled, in-person study visits. Participants were instructed to complete mobile-optimized coital logs as soon as possible after using condoms for anal or vaginal sex acts. The logs collected event-level pleasure and performance measures for the study condoms as well as other relevant data. A questionnaire was administered at the final study visit to assess overall study condom preference. Results: The study enrolled 252 MSM and 252 MSW, a total of 504 participants. MSM and MSW study arms were similar for a number of key traits including race and ethnicity, marital status, self-rated condom experience, and recent experience of condom failure. Men in the MSM arm were older, however, and fewer MSM were students. The majority of participants in both arms rated themselves as very experienced with using condoms, and the majority had used condoms recently. Over one-third of participants in each arm reported experiencing condom failure in the last 6 months. Conclusions: This is the first condom trial to compare the performance of standard, thin, and fitted condoms and to use pleasure and preference as primary outcomes. Given the disparate impact of HIV on MSM, equal enrollment of MSM and MSW was a key feature of this study. Trial results may inform an FDA label indication for anal sex and provide new information regarding the relative performance of different types of condoms. Trial Registration: ClinicalTrials.gov NCT02753842; https://clinicaltrials.gov/ct2/show/NCT02753842 (Archived by WebCite at http://www.webcitation.org/76RLTFyf0) International Registered Report Identifier (IRRID): DERR1-10.2196/12205 UR - https://www.researchprotocols.org/2019/4/e12205/ UR - http://dx.doi.org/10.2196/12205 UR - http://www.ncbi.nlm.nih.gov/pubmed/31012862 ID - info:doi/10.2196/12205 ER - TY - JOUR AU - Fearon, Elizabeth AU - Chabata, T. Sungai AU - Thompson, A. Jennifer AU - Cowan, M. Frances AU - Hargreaves, R. James PY - 2017/09/14 TI - Sample Size Calculations for Population Size Estimation Studies Using Multiplier Methods With Respondent-Driven Sampling Surveys JO - JMIR Public Health Surveill SP - e59 VL - 3 IS - 3 KW - population surveillance KW - sample size KW - sampling studies KW - surveys and questionnaires KW - research design KW - data collection KW - sex workers KW - HIV N2 - Background: While guidance exists for obtaining population size estimates using multiplier methods with respondent-driven sampling surveys, we lack specific guidance for making sample size decisions. Objective: To guide the design of multiplier method population size estimation studies using respondent-driven sampling surveys to reduce the random error around the estimate obtained. Methods: The population size estimate is obtained by dividing the number of individuals receiving a service or the number of unique objects distributed (M) by the proportion of individuals in a representative survey who report receipt of the service or object (P). We have developed an approach to sample size calculation, interpreting methods to estimate the variance around estimates obtained using multiplier methods in conjunction with research into design effects and respondent-driven sampling. We describe an application to estimate the number of female sex workers in Harare, Zimbabwe. Results: There is high variance in estimates. Random error around the size estimate reflects uncertainty from M and P, particularly when the estimate of P in the respondent-driven sampling survey is low. As expected, sample size requirements are higher when the design effect of the survey is assumed to be greater. Conclusions: We suggest a method for investigating the effects of sample size on the precision of a population size estimate obtained using multipler methods and respondent-driven sampling. Uncertainty in the size estimate is high, particularly when P is small, so balancing against other potential sources of bias, we advise researchers to consider longer service attendance reference periods and to distribute more unique objects, which is likely to result in a higher estimate of P in the respondent-driven sampling survey. UR - http://publichealth.jmir.org/2017/3/e59/ UR - http://dx.doi.org/10.2196/publichealth.7909 UR - http://www.ncbi.nlm.nih.gov/pubmed/28912117 ID - info:doi/10.2196/publichealth.7909 ER - TY - JOUR AU - Siegler, J. Aaron AU - Wirtz, Susan AU - Weber, Shannon AU - Sullivan, S. Patrick PY - 2017/09/06 TI - Developing a Web-Based Geolocated Directory of HIV Pre-Exposure Prophylaxis-Providing Clinics: The PrEP Locator Protocol and Operating Procedures JO - JMIR Public Health Surveill SP - e58 VL - 3 IS - 3 KW - HIV prevention, service directory, geolocated database, PrEP N2 - Background: Human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) is highly effective in preventing HIV transmission, yet patients interested in learning more about PrEP or in getting a PrEP prescription may not be able to find local medical providers willing to prescribe PrEP. Objective: We sought to create a national database of PrEP-providing clinics to allow for patients to have access to a unified, vetted source of PrEP providers in an easily accessible database. Methods: To develop the protocol and operating procedures for the PrEP Locator, we conducted a series of 7 key informant interviews with experts who had organized PrEP or other HIV service directories. We convened an external advisory committee and a collaborators board to gain expert and community-situated perspectives. Results: At its public release in September 2016, the database included 1,272 PrEP-providing clinics, including clinics in all 50 states and in Puerto Rico. Web searches, referrals, and outreach to state health departments identified 58 unique lists of PrEP-providing clinics, with 33 from state health departments, 6 from government localities, 2 from professional medical organizations, and 19 from nongovernmental organizations. Out of the 2,420 clinics identified from the lists and Web searches, we removed 798 as duplicate entries, and we determined that 350 were ineligible for listing. The most common reasons for ineligibility were not having the appropriate medical licensure to prescribe PrEP (67/350) or not prescribing PrEP, based on self-report (192/350). Key informant interviews shaped important protocol decisions, such as listing clinics instead of individual clinicians as the primary data element and streamlining data collection to facilitate scalability. We developed a Web interface to provide public access to the data, with geolocated data display, search filter functionality, a webform for public suggestions of new clinics, and a publicly available directory Web tool that can be embedded in websites. In the 6 months following release, preplocator.org and hosting websites had received over 35,000 unique views and 300 clinic additions, and 5 websites had initiated hosting of the widget. Conclusions: Directories exist for many preventive and treatment services. As new medical applications become available, there will be a corresponding need to develop new directories for service provision. Geolocated directories can assist patients in accessing care and have the potential to increase demand for and access to newer, more efficacious medical interventions. Early choices in the development of service directories have long-lasting impact, because once data collection begins, it can be challenging to reverse course. The PrEP Locator protocol may inform early decisions in the development of future service directories. Additionally, the case study on developing the PrEP Locator demonstrates the importance of formative work in identifying service-specific factors that can guide decisions on directory development. UR - http://publichealth.jmir.org/2017/3/e58/ UR - http://dx.doi.org/10.2196/publichealth.7902 UR - http://www.ncbi.nlm.nih.gov/pubmed/28928112 ID - info:doi/10.2196/publichealth.7902 ER - TY - JOUR AU - Spreco, Armin AU - Eriksson, Olle AU - Dahlström, Örjan AU - Cowling, John Benjamin AU - Timpka, Toomas PY - 2017/06/15 TI - Integrated Detection and Prediction of Influenza Activity for Real-Time Surveillance: Algorithm Design JO - J Med Internet Res SP - e211 VL - 19 IS - 6 KW - human influenza KW - algorithms KW - epidemiological surveillance KW - public health surveillance KW - evaluation research KW - epidemiological methods N2 - Background: Influenza is a viral respiratory disease capable of causing epidemics that represent a threat to communities worldwide. The rapidly growing availability of electronic ?big data? from diagnostic and prediagnostic sources in health care and public health settings permits advance of a new generation of methods for local detection and prediction of winter influenza seasons and influenza pandemics. Objective: The aim of this study was to present a method for integrated detection and prediction of influenza virus activity in local settings using electronically available surveillance data and to evaluate its performance by retrospective application on authentic data from a Swedish county. Methods: An integrated detection and prediction method was formally defined based on a design rationale for influenza detection and prediction methods adapted for local surveillance. The novel method was retrospectively applied on data from the winter influenza season 2008-09 in a Swedish county (population 445,000). Outcome data represented individuals who met a clinical case definition for influenza (based on International Classification of Diseases version 10 [ICD-10] codes) from an electronic health data repository. Information from calls to a telenursing service in the county was used as syndromic data source. Results: The novel integrated detection and prediction method is based on nonmechanistic statistical models and is designed for integration in local health information systems. The method is divided into separate modules for detection and prediction of local influenza virus activity. The function of the detection module is to alert for an upcoming period of increased load of influenza cases on local health care (using influenza-diagnosis data), whereas the function of the prediction module is to predict the timing of the activity peak (using syndromic data) and its intensity (using influenza-diagnosis data). For detection modeling, exponential regression was used based on the assumption that the beginning of a winter influenza season has an exponential growth of infected individuals. For prediction modeling, linear regression was applied on 7-day periods at the time in order to find the peak timing, whereas a derivate of a normal distribution density function was used to find the peak intensity. We found that the integrated detection and prediction method detected the 2008-09 winter influenza season on its starting day (optimal timeliness 0 days), whereas the predicted peak was estimated to occur 7 days ahead of the factual peak and the predicted peak intensity was estimated to be 26% lower than the factual intensity (6.3 compared with 8.5 influenza-diagnosis cases/100,000). Conclusions: Our detection and prediction method is one of the first integrated methods specifically designed for local application on influenza data electronically available for surveillance. The performance of the method in a retrospective study indicates that further prospective evaluations of the methods are justified. UR - http://www.jmir.org/2017/6/e211/ UR - http://dx.doi.org/10.2196/jmir.7101 UR - http://www.ncbi.nlm.nih.gov/pubmed/28619700 ID - info:doi/10.2196/jmir.7101 ER - TY - JOUR AU - Rosskam, Ellen AU - Hyder, A. Adnan PY - 2017/05/05 TI - Using mHealth to Predict Noncommunicable Diseases: A Public Health Opportunity for Low- and Middle-Income Countries JO - J Med Internet Res SP - e129 VL - 19 IS - 5 KW - mHealth KW - low- and middle-income countries KW - noncommunicable diseases KW - research agenda KW - population health surveys UR - http://www.jmir.org/2017/5/e129/ UR - http://dx.doi.org/10.2196/jmir.7593 UR - http://www.ncbi.nlm.nih.gov/pubmed/28476727 ID - info:doi/10.2196/jmir.7593 ER - TY - JOUR AU - Labrique, Alain AU - Blynn, Emily AU - Ahmed, Saifuddin AU - Gibson, Dustin AU - Pariyo, George AU - Hyder, A. Adnan PY - 2017/05/05 TI - Health Surveys Using Mobile Phones in Developing Countries: Automated Active Strata Monitoring and Other Statistical Considerations for Improving Precision and Reducing Biases JO - J Med Internet Res SP - e121 VL - 19 IS - 5 KW - surveys and questionnaires KW - sampling studies KW - mobile health KW - mobile phone KW - research methodology UR - http://www.jmir.org/2017/5/e121/ UR - http://dx.doi.org/10.2196/jmir.7329 UR - http://www.ncbi.nlm.nih.gov/pubmed/28476726 ID - info:doi/10.2196/jmir.7329 ER - TY - JOUR AU - Gibson, G. Dustin AU - Pariyo, William George AU - Wosu, C. Adaeze AU - Greenleaf, R. Abigail AU - Ali, Joseph AU - Ahmed, Saifuddin AU - Labrique, B. Alain AU - Islam, Khaleda AU - Masanja, Honorati AU - Rutebemberwa, Elizeus AU - Hyder, A. Adnan PY - 2017/05/05 TI - Evaluation of Mechanisms to Improve Performance of Mobile Phone Surveys in Low- and Middle-Income Countries: Research Protocol JO - JMIR Res Protoc SP - e81 VL - 6 IS - 5 KW - IVR KW - CATI KW - Bangladesh KW - Tanzania KW - Uganda KW - mHealth KW - mobile phone survey KW - noncommunicable diseases KW - survey methodology N2 - Background: Mobile phone ownership and access have increased rapidly across low- and middle-income countries (LMICs) within the last decade. Concomitantly, LMICs are experiencing demographic and epidemiologic transitions, where non-communicable diseases (NCDs) are increasingly becoming leading causes of morbidity and mortality. Mobile phone surveys could aid data collection for prevention and control of these NCDs but limited evidence of their feasibility exists. Objective: The objective of this paper is to describe a series of sub-studies aimed at optimizing the delivery of interactive voice response (IVR) and computer-assisted telephone interviews (CATI) for NCD risk factor data collection in LMICs. These sub-studies are designed to assess the effect of factors such as airtime incentive timing, amount, and structure, survey introduction characteristics, different sampling frames, and survey modality on key survey metrics, such as survey response, completion, and attrition rates. Methods: In a series of sub-studies, participants will be randomly assigned to receive different airtime incentive amounts (eg, 10 minutes of airtime versus 20 minutes of airtime), different incentive delivery timings (airtime delivered before survey begins versus delivery upon completion of survey), different survey introductions (informational versus motivational), different narrative voices (male versus female), and different sampling frames (random digit dialing versus mobile network operator-provided numbers) to examine which study arms will yield the highest response and completion rates. Furthermore, response and completion rates and the inter-modal reliability of the IVR and CATI delivery methods will be compared. Results: Research activities are expected to be completed in Bangladesh, Tanzania, and Uganda in 2017. Conclusions: This is one of the first studies to examine the feasibility of using IVR and CATI for systematic collection of NCD risk factor information in LMICs. Our findings will inform the future design and implementation of mobile phone surveys in LMICs. UR - http://www.researchprotocols.org/2017/5/e81/ UR - http://dx.doi.org/10.2196/resprot.7534 UR - http://www.ncbi.nlm.nih.gov/pubmed/28476729 ID - info:doi/10.2196/resprot.7534 ER - TY - JOUR AU - Hyder, A. Adnan AU - Wosu, C. Adaeze AU - Gibson, G. Dustin AU - Labrique, B. Alain AU - Ali, Joseph AU - Pariyo, W. George PY - 2017/05/05 TI - Noncommunicable Disease Risk Factors and Mobile Phones: A Proposed Research Agenda JO - J Med Internet Res SP - e133 VL - 19 IS - 5 KW - mHealth KW - noncommunicable disease KW - mobile phone KW - research agenda KW - survey UR - http://www.jmir.org/2017/5/e133/ UR - http://dx.doi.org/10.2196/jmir.7246 UR - http://www.ncbi.nlm.nih.gov/pubmed/28476722 ID - info:doi/10.2196/jmir.7246 ER - TY - JOUR AU - Stahlman, Shauna AU - Hargreaves, R. James AU - Sprague, Laurel AU - Stangl, L. Anne AU - Baral, D. Stefan PY - 2017/04/26 TI - Measuring Sexual Behavior Stigma to Inform Effective HIV Prevention and Treatment Programs for Key Populations JO - JMIR Public Health Surveill SP - e23 VL - 3 IS - 2 KW - stigmatization KW - social stigma KW - HIV KW - male homosexuality KW - sex workers N2 - Background: The levels of coverage of human immunodeficiency virus (HIV) treatment and prevention services needed to change the trajectory of the HIV epidemic among key populations, including gay men and other men who have sex with men (MSM) and sex workers, have consistently been shown to be limited by stigma. Objective: The aim of this study was to propose an agenda for the goals and approaches of a sexual behavior stigma surveillance effort for key populations, with a focus on collecting surveillance data from 4 groups: (1) members of key population groups themselves (regardless of HIV status), (2) people living with HIV (PLHIV) who are also members of key populations, (3) members of nonkey populations, and (4) health workers. Methods: We discuss strengths and weaknesses of measuring multiple different types of stigma including perceived, anticipated, experienced, perpetrated, internalized, and intersecting stigma as measured among key populations themselves, as well as attitudes or beliefs about key populations as measured among other groups. Results: With the increasing recognition of the importance of stigma, consistent and validated stigma metrics for key populations are needed to monitor trends and guide immediate action. Evidence-based stigma interventions may ultimately be the key to overcoming the barriers to coverage and retention in life-saving antiretroviral-based HIV prevention and treatment programs for key populations. Conclusions: Moving forward necessitates the integration of validated stigma scales in routine HIV surveillance efforts, as well as HIV epidemiologic and intervention studies focused on key populations, as a means of tracking progress toward a more efficient and impactful HIV response. UR - http://publichealth.jmir.org/2017/2/e23/ UR - http://dx.doi.org/10.2196/publichealth.7334 UR - http://www.ncbi.nlm.nih.gov/pubmed/28446420 ID - info:doi/10.2196/publichealth.7334 ER - TY - JOUR AU - Kesse-Guyot, Emmanuelle AU - Assmann, Karen AU - Andreeva, Valentina AU - Castetbon, Katia AU - Méjean, Caroline AU - Touvier, Mathilde AU - Salanave, Benoît AU - Deschamps, Valérie AU - Péneau, Sandrine AU - Fezeu, Léopold AU - Julia, Chantal AU - Allès, Benjamin AU - Galan, Pilar AU - Hercberg, Serge PY - 2016/10/18 TI - Lessons Learned From Methodological Validation Research in E-Epidemiology JO - JMIR Public Health Surveill SP - e160 VL - 2 IS - 2 KW - cohort studies KW - bias, epidemiology N2 - Background: Traditional epidemiological research methods exhibit limitations leading to high logistics, human, and financial burden. The continued development of innovative digital tools has the potential to overcome many of the existing methodological issues. Nonetheless, Web-based studies remain relatively uncommon, partly due to persistent concerns about validity and generalizability. Objective: The objective of this viewpoint is to summarize findings from methodological studies carried out in the NutriNet-Santé study, a French Web-based cohort study. Methods: On the basis of the previous findings from the NutriNet-Santé e-cohort (>150,000 participants are currently included), we synthesized e-epidemiological knowledge on sample representativeness, advantageous recruitment strategies, and data quality. Results: Overall, the reported findings support the usefulness of Web-based studies in overcoming common methodological deficiencies in epidemiological research, in particular with regard to data quality (eg, the concordance for body mass index [BMI] classification was 93%), reduced social desirability bias, and access to a wide range of participant profiles, including the hard-to-reach subgroups such as young (12.30% [15,118/122,912], <25 years) and old people (6.60% [8112/122,912], ?65 years), unemployed or homemaker (12.60% [15,487/122,912]), and low educated (38.50% [47,312/122,912]) people. However, some selection bias remained (78.00% (95,871/122,912) of the participants were women, and 61.50% (75,590/122,912) had postsecondary education), which is an inherent aspect of cohort study inclusion; other specific types of bias may also have occurred. Conclusions: Given the rapidly growing access to the Internet across social strata, the recruitment of participants with diverse socioeconomic profiles and health risk exposures was highly feasible. Continued efforts concerning the identification of specific biases in e-cohorts and the collection of comprehensive and valid data are still needed. This summary of methodological findings from the NutriNet-Santé cohort may help researchers in the development of the next generation of high-quality Web-based epidemiological studies. UR - http://publichealth.jmir.org/2016/2/e160/ UR - http://dx.doi.org/10.2196/publichealth.5880 UR - http://www.ncbi.nlm.nih.gov/pubmed/27756715 ID - info:doi/10.2196/publichealth.5880 ER - TY - JOUR AU - Devine, Theresa AU - Broderick, Jordan AU - Harris, M. Linda AU - Wu, Huijuan AU - Hilfiker, Williams Sandra PY - 2016/08/02 TI - Making Quality Health Websites a National Public Health Priority: Toward Quality Standards JO - J Med Internet Res SP - e211 VL - 18 IS - 8 KW - online health information KW - health literacy KW - reliability KW - usability KW - measurement N2 - Background: Most US adults have limited health literacy skills. They struggle to understand complex health information and services and to make informed health decisions. The Internet has quickly become one of the most popular places for people to search for information about their health, thereby making access to quality information on the Web a priority. However, there are no standardized criteria for evaluating Web-based health information. Every 10 years, the US Department of Health and Human Services' Office of Disease Prevention and Health Promotion (ODPHP) develops a set of measurable objectives for improving the health of the nation over the coming decade, known as Healthy People. There are two objectives in Healthy People 2020 related to website quality. The first is objective Health Communication and Health Information Technology (HC/HIT) 8.1: increase the proportion of health-related websites that meet 3 or more evaluation criteria for disclosing information that can be used to assess information reliability. The second is objective HC/HIT-8.2: increase the proportion of health-related websites that follow established usability principles. Objective: The ODPHP conducted a nationwide assessment of the quality of Web-based health information using the Healthy People 2020 objectives. The ODPHP aimed to establish (1) a standardized approach to defining and measuring the quality of health websites; (2) benchmarks for measurement; (3) baseline data points to capture the current status of website quality; and (4) targets to drive improvement. Methods: The ODPHP developed the National Quality Health Website Survey instrument to assess the quality of health-related websites. The ODPHP used this survey to review 100 top-ranked health-related websites in order to set baseline data points for these two objectives. The ODPHP then set targets to drive improvement by 2020. Results: This study reviewed 100 health-related websites. For objective HC/HIT-8.1, a total of 58 out of 100 (58.0%) websites met 3 or more out of 6 reliability criteria. For objective HC/HIT-8.2, a total of 42 out of 100 (42.0%) websites followed 10 or more out of 19 established usability principles. On the basis of these baseline data points, ODPHP set targets for the year 2020 that meet the minimal statistical significance?increasing objective HC/HIT-8.1 data point to 70.5% and objective HC/HIT-8.2 data point to 55.7%. Conclusions: This research is a critical first step in evaluating the quality of Web-based health information. The criteria proposed by ODPHP provide methods to assess website quality for professionals designing, developing, and managing health-related websites. The criteria, baseline data, and targets are valuable tools for driving quality improvement. UR - http://www.jmir.org/2016/8/e211/ UR - http://dx.doi.org/10.2196/jmir.5999 UR - http://www.ncbi.nlm.nih.gov/pubmed/27485512 ID - info:doi/10.2196/jmir.5999 ER - TY - JOUR AU - Jones, K. Marcella AU - Calzavara, Liviana AU - Allman, Dan AU - Worthington, A. Catherine AU - Tyndall, Mark AU - Iveniuk, James PY - 2016/07/29 TI - A Comparison of Web and Telephone Responses From a National HIV and AIDS Survey JO - JMIR Public Health Surveill SP - e37 VL - 2 IS - 2 KW - survey methods KW - cross-sectional survey KW - community survey KW - HIV KW - AIDS KW - social desirability KW - data collection methods KW - data quality KW - health attitude KW - health knowledge KW - attitudes KW - practice N2 - Background: Response differences to survey questions are known to exist for different modes of questionnaire completion. Previous research has shown that response differences by mode are larger for sensitive and complicated questions. However, it is unknown what effect completion mode may have on HIV and AIDS survey research, which addresses particularly sensitive and stigmatized health issues. Objectives: We seek to compare responses between self-selected Web and telephone respondents in terms of social desirability and item nonresponse in a national HIV and AIDS survey. Methods: A survey of 2085 people in Canada aged 18 years and older was conducted to explore public knowledge, attitudes, and behaviors around HIV and AIDS in May 2011. Participants were recruited using random-digit dialing and could select to be interviewed on the telephone or self-complete through the Internet. For this paper, 15 questions considered to be either sensitive, stigma-related, or less-sensitive in nature were assessed to estimate associations between responses and mode of completion. Multivariate regression analyses were conducted for questions with significant (P?.05) bivariate differences in responses to adjust for sociodemographic factors. As survey mode was not randomly assigned, we created a propensity score variable and included it in our multivariate models to control for mode selection bias. Results: A total of 81% of participants completed the questionnaire through the Internet, and 19% completed by telephone. Telephone respondents were older, reported less education, had lower incomes, and were more likely from the province of Quebec. Overall, 2 of 13 questions assessed for social desirability and 3 of 15 questions assessed for item nonresponse were significantly associated with choice of mode in the multivariate analysis. For social desirability, Web respondents were more likely than telephone respondents to report more than 1 sexual partner in the past year (fully adjusted odds ratio (OR)=3.65, 95% CI 1.80-7.42) and more likely to have donated to charity in the past year (OR=1.63, 95% CI 1.15-2.29). For item nonresponse, Web respondents were more likely than telephone respondents to have a missing or ?don?t know? response when asked about: the disease they were most concerned about (OR=3.02, 95% CI 1.67-5.47); if they had ever been tested for HIV (OR=8.04, 95% CI 2.46-26.31); and when rating their level of comfort with shopping at grocery store if the owner was known to have HIV or AIDS (OR=3.11, 95% CI 1.47-6.63). Conclusion: Sociodemographic differences existed between Web and telephone respondents, but for 23 of 28 questions considered in our analysis, there were no significant differences in responses by mode. For surveys with very sensitive health content, such as HIV and AIDS, Web administration may be subject to less social desirability bias but may also have greater item nonresponse for certain questions. UR - http://publichealth.jmir.org/2016/2/e37/ UR - http://dx.doi.org/10.2196/publichealth.5184 UR - http://www.ncbi.nlm.nih.gov/pubmed/27473597 ID - info:doi/10.2196/publichealth.5184 ER - TY - JOUR AU - Rossing, Emil AU - Ravn, Henrik AU - Batista, Pereira Celso Soares AU - Rodrigues, Amabelia PY - 2016/07/27 TI - MHealth to Improve Measles Immunization in Guinea-Bissau: Study Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e158 VL - 5 IS - 3 KW - mHealth KW - eHealth KW - SMS reminders KW - voice reminders KW - Guinea-Bissau, ODK KW - Africa KW - RapidSMS KW - health systems strengthening KW - randomized controlled trial KW - measles KW - immunization N2 - Background: Recent studies have revealed a low measles vaccination (MV) rate in the Republic of Guinea-Bissau (West Africa) that has not increased in accordance with the increasing coverage of other vaccinations. Measles is the deadliest of all childhood rash/fever illnesses and spreads easily, implying that if the vaccination coverage is declining there is a significant risk of new measles outbreaks [27]. Meanwhile, mobile health (mHealth; the use of mobile phones for health interventions) has generated much enthusiasm, and shown potential in improving health service delivery in other contexts. Objective: The aim of this study is to evaluate the efficiency of mHealth as a tool for improving MV coverage while contributing to the mHealth evidence base. Methods: This study will take place at three health centers in different regions of Guinea-Bissau. Participants, defined as mothers of the children receiving the MV, will be enrolled when they arrive with their children at the health center to receive the Bacillus Calmette-Guérin vaccination, usually within one month of the child?s birth. Enrolment will continue until a study population of 990 children has been reached. The participants will be randomly assigned to a control arm or one of two intervention arms. Each of the three groups will have 330 participants, distributed equally between health centers. Participants in the first intervention arm will receive a scheduled short message service (SMS) text message reminding them of the MV. Participants in the second intervention arm will receive a voice call in addition to the SMS message, while the control arm will receive no interventions. The MV is scheduled to be administered at 9 months of age. Although the vaccine would still be effective after 12 months, local policy in Guinea-Bissau prevents children aged >12 months from receiving the vaccination, and thus the study will follow-up with participants after the children reach 12 months of age. Children who have not yet received the MV will be offered vaccination by the project group. Results: The study will analyze the efficiency of the intervention by determining its overall effect on MV coverage and timeliness when children reach 12 months of age. The main analysis will be stratified by intervention group, health center, level of education, ethnic group, and role of the person receiving the text messages (eg, mother, father, other family member). Secondary outcomes include the average number of health center visits (with intention to obtain the MV) required before successful administration. Conclusions: Despite the rapid proliferation of mHealth projects, only a small number have been evaluated in terms of direct links to health outcomes. This gap in knowledge requires solid evidence on which policy-makers can base decisions. This study aims to produce significant knowledge about mHealth implementation within a Sub-Saharan context while creating data-supported evidence. Trial Registration: Clinicaltrials.gov: NCT02662595; https://clinicaltrials.gov/ct2/show/NCT02662595 (Archived by WebCite at http://www.webcitation.org/6jH8YiSjY) UR - http://www.researchprotocols.org/2016/3/e158/ UR - http://dx.doi.org/10.2196/resprot.5968 UR - http://www.ncbi.nlm.nih.gov/pubmed/27466046 ID - info:doi/10.2196/resprot.5968 ER - TY - JOUR AU - Kandula, R. Namratha AU - Puri-Taneja, Ankita AU - Victorson, E. David AU - Dave, S. Swapna AU - Kanaya, M. Alka AU - Huffman, D. Mark PY - 2016/06/08 TI - Mediators of Atherosclerosis in South Asians Living in America: Use of Web-Based Methods for Follow-Up and Collection of Patient-Reported Outcome Measures JO - JMIR Res Protoc SP - e95 VL - 5 IS - 2 KW - cardiovascular diseases KW - cohort studies KW - Internet KW - South Asian N2 - Background: A key challenge for longitudinal cohort studies is follow-up and retention of study participants. Participant follow-up in longitudinal cohort studies is costly and time-consuming for research staff and participants. Objective: This study determined the feasibility and costs of using Web-based technologies for follow-up and collection of patient-reported outcomes in the Mediators of Atherosclerosis in South Asians Living in America (MASALA) study. Methods: The MASALA study is a community-based cohort of 906 South Asians in the United States. Since the baseline in-person visits (2010-2013), a yearly telephone follow-up survey was used to assess participants? health status and incidence of cardiovascular disease. A Web-based version of the follow-up survey was developed using the REDCap (Research Electronic Data Capture) Web app. Participants from the Chicago field center who were due for their annual follow-up and who had a valid email address were sent an email link to a secure online portal where they could complete the survey. Telephone follow-up was used with nonresponders. Results: A link to the Web survey was emailed to 285 participants (February to October 2014) and the overall completion rate was 47.7% (136/285). One-third of participants who were unresponsive (n=36) to annual telephone follow-up completed the Web survey. Web responders were younger, more likely to be married, and to have higher education and income compared (P<.05) to telephone-only responders. Web survey development involved 240 hours of research staff time. Since launching, the Web-based survey has required 3 hours per week of staff time. Conclusions: Although electronic follow-up will not be a panacea for cohort operations, it will serve as an adjunctive strategy to telephonic follow-up for maximizing cohort retention with lower costs. UR - http://www.researchprotocols.org/2016/2/e95/ UR - http://dx.doi.org/10.2196/resprot.5448 UR - http://www.ncbi.nlm.nih.gov/pubmed/27278905 ID - info:doi/10.2196/resprot.5448 ER - TY - JOUR AU - McIntosh, Scott AU - Pérez-Ramos, José AU - Demment, M. Margaret AU - Vélez Vega, Carmen AU - Avendaño, Esteban AU - Ossip, J. Deborah AU - Dye, D. Timothy PY - 2016/06/02 TI - Development and Implementation of Culturally Tailored Offline Mobile Health Surveys JO - JMIR Public Health Surveill SP - e28 VL - 2 IS - 1 KW - mobile health KW - survey research KW - ethical review N2 - Background: In low and middle income countries (LMICs), and other areas with low resources and unreliable access to the Internet, understanding the emerging best practices for the implementation of new mobile health (mHealth) technologies is needed for efficient and secure data management and for informing public health researchers. Innovations in mHealth technology can improve on previous methods, and dissemination of project development details and lessons learned during implementation are needed to provide lessons learned to stakeholders in both the United States and LMIC settings. Objective: The aims of this paper are to share implementation strategies and lessons learned from the development and implementation stages of two survey research projects using offline mobile technology, and to inform and prepare public health researchers and practitioners to implement new mobile technologies in survey research projects in LMICs. Methods: In 2015, two survey research projects were developed and piloted in Puerto Rico and pre-tested in Costa Rica to collect face-to-face data, get formative evaluation feedback, and to test the feasibility of an offline mobile data collection process. Fieldwork in each setting involved survey development, back translation with cultural tailoring, ethical review and approvals, data collector training, and piloting survey implementation on mobile tablets. Results: Critical processes and workflows for survey research projects in low resource settings were identified and implemented. This included developing a secure mobile data platform tailored to each survey, establishing user accessibility, and training and eliciting feedback from data collectors and on-site LMIC project partners. Conclusions: Formative and process evaluation strategies are necessary and useful for the development and implementation of survey research projects using emerging mHealth technologies in LMICs and other low resource settings. Lessons learned include: (1) plan institutional review board (IRB) approvals in multiple countries carefully to allow for development, implementation, and feedback, (2) in addition to testing the content of survey instruments, allow time and consideration for testing the use of novel mHealth technology (hardware and software), (3) incorporate training for and feedback from project staff, LMIC partner staff, and research participants, and (4) change methods accordingly, including content, as mHealth technology usage influences and is influenced by the content and structure of the survey instrument. Lessons learned from early phases of LMIC research projects using emerging mHealth technologies are critical for informing subsequent research methods and study designs. UR - http://publichealth.jmir.org/2016/1/e28/ UR - http://dx.doi.org/10.2196/publichealth.5408 UR - http://www.ncbi.nlm.nih.gov/pubmed/27256208 ID - info:doi/10.2196/publichealth.5408 ER - TY - JOUR AU - Norman, D. Cameron AU - Haresign, Helen AU - Mehling, Christine AU - Bloomberg, Honey PY - 2016/04/19 TI - Exploring the Feasibility and Potential of Virtual Panels for Soliciting Feedback on Nutrition Education Materials: A Proof-of-Concept Study JO - JMIR Public Health Surveill SP - e18 VL - 2 IS - 1 KW - health communications KW - Facebook KW - marketing KW - nutrition KW - nutrition education KW - healthy eating KW - health education KW - design KW - study design KW - social media KW - user design KW - qualitative data KW - health promotion KW - public health N2 - Background: A changing and cluttered information landscape has put pressure on health organizations to produce consumer information materials that are not only factual but high quality and engaging to audiences. User-centered design methods can be useful in obtaining feedback from consumers; however, they are labor intensive and slow, which is not responsive to the fast-paced communication landscape influenced by social media. EatRight Ontario (ERO), a provincial nutrition and health support program of Dietitians of Canada, develops evidence-based resources for consumers and sought to increase user-centered design activities by exploring whether the standard approach to feedback could be replicated online. While online feedback has been used in marketing research, few examples are available in health promotion and public health to guide programming and policy. Objective: This study compared a traditional in-person approach for recruitment and feedback using paper surveys with an Internet-based approach using Facebook as a recruitment tool and collecting user feedback via the Web. The purpose of the proof-of-concept study was to explore the feasibility of the approach and compare an online versus traditional approach in terms of recruitment issues and response. Methods: An exploratory, two-group comparative trial was conducted using a convenience and purposive sampling. Participants reviewed a handout on healthy eating and then completed an 18-item survey with both forced-choice items and open-ended responses. One group viewed a hard-copy prototype and completed a paper survey and the other viewed a PDF prototype via Web links and completed a Web survey. The total days required to fulfill the sample for each group were used as the primary method of efficiency calculation. Results: In total, 44 participants (22 per condition) completed the study, consisting of 42 women and 2 men over the age of 18. Few significant differences were detected between the groups. Statistically significant (P?.05) differences were detected on four attitudinal variables related to the document reviewed and include perceived length of the document, perceived attractiveness, likelihood of contacting ERO for food and nutrition questions in the future, and likelihood of recommending ERO to a friend. In all cases, the responses were more favorable to the document or ERO with the online group. All other variables showed no difference between them. A content review of the qualitative feedback found relative consistency in word use and number of words used, indicating relative parity in the amount of data generated between conditions. The online condition achieved its sampling target in 9 days, while the in-person method took 79 days to achieve the target. Conclusions: An online process of recruitment through Facebook and solicitation of online feedback is a feasible model that yields comparable response levels to in-person methods for user feedback. The online approach appears to be a faster and less resource-intensive approach than traditional in-person methods for feedback generation. UR - http://publichealth.jmir.org/2016/1/e18/ UR - http://dx.doi.org/10.2196/publichealth.5134 UR - http://www.ncbi.nlm.nih.gov/pubmed/27227153 ID - info:doi/10.2196/publichealth.5134 ER - TY - JOUR AU - Ocampo, F. Joanne Michelle AU - Smart, JC AU - Allston, Adam AU - Bhattacharjee, Reshma AU - Boggavarapu, Sahithi AU - Carter, Sharon AU - Castel, D. Amanda AU - Collmann, Jeff AU - Flynn, Colin AU - Hamp, Auntré AU - Jordan, Diana AU - Kassaye, Seble AU - Kharfen, Michael AU - Lum, Garret AU - Pemmaraju, Raghu AU - Rhodes, Anne AU - Stover, Jeff AU - Young, A. Mary PY - 2016/01/15 TI - Improving HIV Surveillance Data for Public Health Action in Washington, DC: A Novel Multiorganizational Data-Sharing Method JO - JMIR Public Health Surveill SP - e3 VL - 2 IS - 1 KW - HIV KW - surveillance KW - data sharing KW - public health KW - technology N2 - Background: The National HIV/AIDS Strategy calls for active surveillance programs for human immunodeficiency virus (HIV) to more accurately measure access to and retention in care across the HIV care continuum for persons living with HIV within their jurisdictions and to identify persons who may need public health services. However, traditional public health surveillance methods face substantial technological and privacy-related barriers to data sharing. Objective: This study developed a novel data-sharing approach to improve the timeliness and quality of HIV surveillance data in three jurisdictions where persons may often travel across the borders of the District of Columbia, Maryland, and Virginia. Methods: A deterministic algorithm of approximately 1000 lines was developed, including a person-matching system with Enhanced HIV/AIDS Reporting System (eHARS) variables. Person matching was defined in categories (from strongest to weakest): exact, very high, high, medium high, medium, medium low, low, and very low. The algorithm was verified using conventional component testing methods, manual code inspection, and comprehensive output file examination. Results were validated by jurisdictions using internal review processes. Results: Of 161,343 uploaded eHARS records from District of Columbia (N=49,326), Maryland (N=66,200), and Virginia (N=45,817), a total of 21,472 persons were matched across jurisdictions over various strengths in a matching process totaling 21 minutes and 58 seconds in the privacy device, leaving 139,871 uniquely identified with only one jurisdiction. No records matched as medium low or low. Over 80% of the matches were identified as either exact or very high matches. Three separate validation methods were conducted for this study, and they all found ?90% accuracy between records matched by this novel method and traditional matching methods. Conclusions: This study illustrated a novel data-sharing approach that may facilitate timelier and better quality HIV surveillance data for public health action by reducing the effort needed for traditional person-matching reviews without compromising matching accuracy. Future analyses will examine the generalizability of these findings to other applications. UR - http://publichealth.jmir.org/2016/1/e3/ UR - http://dx.doi.org/10.2196/publichealth.5317 UR - http://www.ncbi.nlm.nih.gov/pubmed/27227157 ID - info:doi/10.2196/publichealth.5317 ER - TY - JOUR AU - Pezaro, Sally AU - Clyne, Wendy PY - 2015/09/04 TI - Achieving Consensus in the Development of an Online Intervention Designed to Effectively Support Midwives in Work-Related Psychological Distress: Protocol for a Delphi Study JO - JMIR Res Protoc SP - e107 VL - 4 IS - 3 KW - Delphi technique KW - Internet KW - intervention studies KW - midwifery KW - psychological KW - research protocols KW - self-help groups KW - stress N2 - Background: The development of an online intervention designed to effectively support midwives in work-related psychological distress will be challenging due to the ethical, practical, and therapeutic issues surrounding its design. Related literature suggests that midwives may require an anonymous, confidential, and therapeutic platform that facilitates amnesty and nonpunitive approaches to remedy ill health. However, it is unclear which requirements may be most salient to midwifery populations. Objective: The objective of this paper is to describe the design of a Delphi study, intended to achieve expert consensus on the needs of midwives in work-related psychological distress who may be supported via an online intervention. This protocol may also serve as a research framework for similar studies to be modeled upon. Methods: A heterogeneous sample of at least thirty experts on psychological well-being and distress associated with midwifery work will be recruited. Their opinions regarding the development of an online intervention designed to support midwives in work-related psychological distress will be collected through 2 rounds of questioning, via the Delphi Technique. When 60% (?18, assuming the minimum is 30) of panelists score within 2 adjacent points on a 7-point scale, consensus will be acknowledged. This Delphi study protocol will invite both qualitative and quantitative outcomes. Results: This study is currently in development. It is financially supported by a full-time scholarship at the Centre for Technology Enabled Health Research at Coventry University (Coventry, UK). The implementation of this Delphi study is anticipated to occur during the autumn of 2015. Conclusions: The results of this study will direct the development of an online intervention designed to support midwives in work-related psychological distress, summarize expert driven consensus, and direct future research. UR - http://www.researchprotocols.org/2015/3/e107/ UR - http://dx.doi.org/10.2196/resprot.4766 UR - http://www.ncbi.nlm.nih.gov/pubmed/26341794 ID - info:doi/10.2196/resprot.4766 ER - TY - JOUR AU - Arayasirikul, Sean AU - Cai, Xiang AU - Wilson, C. Erin PY - 2015/08/25 TI - A Qualitative Examination of Respondent-Driven Sampling (RDS) Peer Referral Challenges Among Young Transwomen in the San Francisco Bay Area JO - JMIR Public Health Surveill SP - e9 VL - 1 IS - 2 KW - transgenders KW - young adults KW - qualitative research KW - epidemiology KW - methodology N2 - Background: Efforts have focused on developing innovative recruitment strategies to engage the most marginalized of populations in public health research. Respondent-driven sampling (RDS) has been found to be an effective sampling strategy for hard-to-reach, hidden populations. Though studies have documented RDS peer referral as challenging, literature contextualizing these challenges is scant and rarely do they discuss the role of Internet technologies. Objective: The objective of the study was to explore reasons for peer referral challenges in a human immunodeficiency virus (HIV) risk and resilience study among a hidden population of youth, specifically, young transwomen. These findings amplify the unique opportunities Internet technologies bring to public health research and methodology. Methods: We conducted focused, semistructured, qualitative interviews with 16 young transwomen to investigate the reasons why youth did or did not refer peers to an RDS study for transwomen ages 16-24 in the San Francisco Bay Area. Qualitative interview data were coded and analyzed using grounded theory. Results: Participants discussed specific barriers and facilitators related to four factors that include study design, study implementation, community characteristics, and individual characteristics, which contributed to RDS peer referral challenges. Conclusions: Our grounded theory analysis identifies important considerations for future RDS studies with hidden youth populations. Exploring research participants? experiences is integral in strengthening future epidemiologic research efforts that plan to use RDS to sample and estimate the hidden epidemics among at-risk youth and transgender women. Additionally, Internet technologies and Web-based adaptations offer solutions to traditional RDS peer referral challenges, having the potential to increase accessibility and use among hidden youth populations. UR - http://publichealth.jmir.org/2015/2/e9/ UR - http://dx.doi.org/10.2196/publichealth.4573 UR - http://www.ncbi.nlm.nih.gov/pubmed/27227143 ID - info:doi/10.2196/publichealth.4573 ER - TY - JOUR AU - Lewis, Lorchan Thomas AU - Wyatt, C. Jeremy PY - 2015/08/19 TI - App Usage Factor: A Simple Metric to Compare the Population Impact of Mobile Medical Apps JO - J Med Internet Res SP - e200 VL - 17 IS - 8 KW - mHealth KW - medical app KW - mobile phone KW - metric KW - risk assessment KW - medical informatics apps KW - population impact KW - mobile health KW - patient safety KW - mobile app N2 - Background: One factor when assessing the quality of mobile apps is quantifying the impact of a given app on a population. There is currently no metric which can be used to compare the population impact of a mobile app across different health care disciplines. Objective: The objective of this study is to create a novel metric to characterize the impact of a mobile app on a population. Methods: We developed the simple novel metric, app usage factor (AUF), defined as the logarithm of the product of the number of active users of a mobile app with the median number of daily uses of the app. The behavior of this metric was modeled using simulated modeling in Python, a general-purpose programming language. Three simulations were conducted to explore the temporal and numerical stability of our metric and a simulated app ecosystem model using a simulated dataset of 20,000 apps. Results: Simulations confirmed the metric was stable between predicted usage limits and remained stable at extremes of these limits. Analysis of a simulated dataset of 20,000 apps calculated an average value for the app usage factor of 4.90 (SD 0.78). A temporal simulation showed that the metric remained stable over time and suitable limits for its use were identified. Conclusions: A key component when assessing app risk and potential harm is understanding the potential population impact of each mobile app. Our metric has many potential uses for a wide range of stakeholders in the app ecosystem, including users, regulators, developers, and health care professionals. Furthermore, this metric forms part of the overall estimate of risk and potential for harm or benefit posed by a mobile medical app. We identify the merits and limitations of this metric, as well as potential avenues for future validation and research. UR - http://www.jmir.org/2015/8/e200/ UR - http://dx.doi.org/10.2196/jmir.4284 UR - http://www.ncbi.nlm.nih.gov/pubmed/26290093 ID - info:doi/10.2196/jmir.4284 ER - TY - JOUR AU - Smith, Katherine AU - Washington, Carmen AU - Brown, Jennifer AU - Vadnais, Alison AU - Kroart, Laura AU - Ferguson, Jacqueline AU - Cohen, Joanna PY - 2015/08/12 TI - The Tobacco Pack Surveillance System: A Protocol for Assessing Health Warning Compliance, Design Features, and Appeals of Tobacco Packs Sold in Low- and Middle-Income Countries JO - JMIR Public Health Surveill SP - e8 VL - 1 IS - 2 KW - tobacco products KW - cigarettes KW - public health surveillance KW - health communication KW - national health policy KW - marketing KW - developing countries N2 - Background: Tobacco remains the world?s leading preventable cause of death, with the majority of tobacco-caused deaths occurring in low- and middle-income countries. The first global health treaty, the Framework Convention on Tobacco Control (FCTC), outlines a set of policy initiatives that have been demonstrated as effective in reducing tobacco use. Article 11 of the FCTC focuses on using the tobacco package to communicate tobacco-caused harms; it also seeks to restrict the delivery of misleading information about the product on the pack. Objective: The objective of this study was to establish a surveillance system for tobacco packs in the 14 low- and middle-income countries with the greatest number of smokers. The Tobacco Pack Surveillance System (TPackSS) monitors whether required health warnings on tobacco packages are being implemented as intended, and identifies pack designs and appeals that might violate or detract from the communication of harm-related information and undermine the impact of a country?s tobacco packaging laws. The protocol outlined is intended to be applicable or adaptable for surveillance efforts in other countries. Methods: Tobacco packs were collected in 14 countries during 2013. The intention was, to the extent possible, to construct a census of ?unique? pack presentations available for purchase in each country. The TPackSS team partnered with in-country field staff to implement a standardized protocol for acquiring packs from 36 diverse neighborhoods across three cities in each country. At the time of purchase, data on price and place of acquisition of each pack was recorded. The field staff, according to a standardized protocol, then photographed packs before they were shipped to the United States for coding and archiving. Results: Each pack was coded for compliance with the country-specific health warning label laws, as well as for key design features of the pack and appeals of the branding elements. The coding protocols were developed based upon prior research, expert opinion, and communication theories. Each pack was coded by two independent coders, with consistency of personnel across the project. We routinely measured intercoder reliability, and only retained variables for which a good level of reliability was achieved. Variables where reliability was too low were not included in final analyses, and any inconsistencies in coding were resolved on a daily basis. Conclusions: Across the 14 countries, the TPackSS team collected 3307 tobacco packs. We have established a publicly accessible, Internet archive of these packs that is intended for use by the tobacco control policy advocacy and research community. UR - http://publichealth.jmir.org/2015/2/e8/ UR - http://dx.doi.org/10.2196/publichealth.4616 UR - http://www.ncbi.nlm.nih.gov/pubmed/27227142 ID - info:doi/10.2196/publichealth.4616 ER - TY - JOUR AU - Gelormini, Marcello AU - Damasceno, Albertino AU - Lopes, António Simão AU - Maló, Sérgio AU - Chongole, Célia AU - Muholove, Paulino AU - Casal, Susana AU - Pinho, Olívia AU - Moreira, Pedro AU - Padrão, Patrícia AU - Lunet, Nuno PY - 2015/08/05 TI - Street Food Environment in Maputo (STOOD Map): a Cross-Sectional Study in Mozambique JO - JMIR Res Protoc SP - e98 VL - 4 IS - 3 KW - fast foods KW - commerce KW - marketing KW - Mozambique N2 - Background: Street food represents a cultural, social, and economic phenomenon that is typical of urbanized areas, directly linked with a more sedentary lifestyle and providing a very accessible and inexpensive source of nutrition. Food advertising may contribute to shaping consumers? preferences and has the potential to drive the supply of specific foods. Objective: The purpose of this study is to characterize the street food offerings available to the urban population of Maputo, the capital city of Mozambique, and the billboard food advertising in the same setting. Methods: People selling ready-to-eat foods, beverages, or snacks from venues such as carts, trucks, stands, and a variety of improvised informal setups (eg, shopping carts, trunks of cars, sides of vans, blankets on the sidewalk, etc) will be identified in the district of KaMpfumu. We will gather information about the actual food being sold through direct observation and interviews to vendors, and from the billboard advertising in the same areas. A second phase of the research entails collecting food samples to be analyzed in a specialized laboratory. The street food environment will be characterized, overall and according to socioeconomic and physical characteristics of the neighborhood, using descriptive statistics and spatial analysis. The study protocol was approved by the National Committee for Bioethics for Health in Mozambique. Results: Data collection, including the identification of street food vending sites and billboard advertising, started on October 20, 2014, and lasted for 1 month. The collection of food samples took place in December 2014, and the bromatological analyses are expected to be concluded in August 2015. Conclusions: The district of KaMpfumu is the wealthiest and most urbanized in Maputo, and it is the area with the highest concentration and variety of street food vendors. The expected results may yield important information to assess the nutritional environment and the characteristics of the foods to which a great majority of the urban population living or working in Maputo are exposed. Furthermore, this study protocol provides a framework for a stepwise standardized characterization of the street food environment, comprising 3 steps with increasing complexity and demand for human and technical resources: Step 1 consists of the evaluation of food advertising in the streets; Step 2 includes the identification of street food vendors and the characterization of the products available; and Step 3 requires the collection of food samples for bromatological analyses. This structured approach to the assessment of the street food environment may enable within-country and international comparisons as well as monitoring of temporal trends. UR - http://www.researchprotocols.org/2015/3/e98/ UR - http://dx.doi.org/10.2196/resprot.4096 UR - http://www.ncbi.nlm.nih.gov/pubmed/26245231 ID - info:doi/10.2196/resprot.4096 ER - TY - JOUR AU - Hoen, G. Anne AU - Hladish, J. Thomas AU - Eggo, M. Rosalind AU - Lenczner, Michael AU - Brownstein, S. John AU - Meyers, Ancel Lauren PY - 2015/07/08 TI - Epidemic Wave Dynamics Attributable to Urban Community Structure: A Theoretical Characterization of Disease Transmission in a Large Network JO - J Med Internet Res SP - e169 VL - 17 IS - 7 KW - communicable diseases KW - epidemics KW - transmission N2 - Background: Multiple waves of transmission during infectious disease epidemics represent a major public health challenge, but the ecological and behavioral drivers of epidemic resurgence are poorly understood. In theory, community structure?aggregation into highly intraconnected and loosely interconnected social groups?within human populations may lead to punctuated outbreaks as diseases progress from one community to the next. However, this explanation has been largely overlooked in favor of temporal shifts in environmental conditions and human behavior and because of the difficulties associated with estimating large-scale contact patterns. Objective: The aim was to characterize naturally arising patterns of human contact that are capable of producing simulated epidemics with multiple wave structures. Methods: We used an extensive dataset of proximal physical contacts between users of a public Wi-Fi Internet system to evaluate the epidemiological implications of an empirical urban contact network. We characterized the modularity (community structure) of the network and then estimated epidemic dynamics under a percolation-based model of infectious disease spread on the network. We classified simulated epidemics as multiwave using a novel metric and we identified network structures that were critical to the network?s ability to produce multiwave epidemics. Results: We identified robust community structure in a large, empirical urban contact network from which multiwave epidemics may emerge naturally. This pattern was fueled by a special kind of insularity in which locally popular individuals were not the ones forging contacts with more distant social groups. Conclusions: Our results suggest that ordinary contact patterns can produce multiwave epidemics at the scale of a single urban area without the temporal shifts that are usually assumed to be responsible. Understanding the role of community structure in epidemic dynamics allows officials to anticipate epidemic resurgence without having to forecast future changes in hosts, pathogens, or the environment. UR - http://www.jmir.org/2015/7/e169/ UR - http://dx.doi.org/10.2196/jmir.3720 UR - http://www.ncbi.nlm.nih.gov/pubmed/26156032 ID - info:doi/10.2196/jmir.3720 ER - TY - JOUR AU - Soong, Andrea AU - Chen, Cen Julia AU - Borzekowski, LG Dina PY - 2015/06/24 TI - Using Ecological Momentary Assessment to Study Tobacco Behavior in Urban India: There?s an App for That JO - JMIR Res Protoc SP - e76 VL - 4 IS - 2 KW - ecological momentary assessment KW - tobacco control KW - cell phones KW - mobile phones KW - mHealth KW - telemedicine KW - smoking N2 - Background: Ecological momentary assessment (EMA) uses real-time data collection to assess participants? behaviors and environments. This paper explores the strengths and limitations of using EMA to examine social and environmental exposure to tobacco in urban India among older adolescents and adults. Objective: Objectives of this study were (1) to describe the methods used in an EMA study of tobacco use in urban India using a mobile phone app for data collection, (2) to determine the feasibility of using EMA in the chosen setting by drawing on participant completion and compliance rates with the study protocol, and (3) to provide recommendations on implementing mobile phone EMA research in India and other low- and middle-income countries. Methods: Via mobile phones and the Internet, this study used two EMA surveys: (1) a momentary survey, sent multiple times per day at random to participants, which asked about their real-time tobacco use (smoked and smokeless) and exposure to pro- and antitobacco messaging in their location, and 2) an end-of-day survey sent at the end of each study day. Trained participants, from Hyderabad and Kolkata, India, reported on their social and environmental exposure to tobacco over 10 consecutive days. This feasibility study examined participant compliance, exploring factors related to the successful completion of surveys and the validity of EMA data. Results: The sample included 205 participants, the majority of whom were male (135/205, 65.9%). Almost half smoked less than daily (56/205, 27.3%) or daily (43/205, 21.0%), and 4.4% (9/205) used smokeless tobacco products. Participants completed and returned 46.87% and 73.02% of momentary and end-of-day surveys, respectively. Significant predictors of momentary survey completion included employment and completion of end-of-day surveys. End-of-day survey completion was only significantly predicted by momentary survey completion. Conclusions: This first study of EMA in India offers promising results, although more research is needed on how to increase compliance. End-of-day survey completion, which has a lower research burden, may be the more appropriate approach to understanding behaviors such as tobacco use within vulnerable populations in challenging locations. Compliance may also be improved by increasing the number of study visits, compliance checks, or opportunities for retraining participants before and during data collection. UR - http://www.researchprotocols.org/2015/2/e76/ UR - http://dx.doi.org/10.2196/resprot.4408 UR - http://www.ncbi.nlm.nih.gov/pubmed/26109369 ID - info:doi/10.2196/resprot.4408 ER - TY - JOUR AU - Krishnadath, SK Ingrid AU - Smits, CF Christel AU - Jaddoe, WV Vincent AU - Hofman, Albert AU - Toelsie, R. Jerry PY - 2015/06/17 TI - A National Surveillance Survey on Noncommunicable Disease Risk Factors: Suriname Health Study Protocol JO - JMIR Res Protoc SP - e75 VL - 4 IS - 2 KW - ethnicity KW - multistage cluster sample KW - noncommunicable disease risk factors KW - STEPwise approach to surveillance KW - Suriname N2 - Background: Noncommunicable diseases (NCDs) are the leading cause of death in low- and middle-income countries. Therefore, the surveillance of risk factors has become an issue of major importance for planning and implementation of preventive measures. Unfortunately, in these countries data on NCDs and their risk factors are limited. This also prevails in Suriname, a middle-income country of the Caribbean, with a multiethnic/multicultural population living in diverse residential areas. For these reasons, ?The Suriname Health Study? was designed. Objective: The main objective of this study is to estimate the prevalence of NCD risk factors, including metabolic syndrome, hypertension, and diabetes in Suriname. Differences between specific age groups, sexes, ethnic groups, and geographical areas will be emphasized. In addition, risk groups will be identified and targeted actions will be designed and evaluated. Methods: In this study, several methodologies were combined. A stratified multistage cluster sample was used to select the participants of 6 ethnic groups (Hindustani, Creole, Javanese, Maroon, Chinese, Amerindians, and mixed) divided into 5 age groups (between 15 and 65 years) who live in urban/rural areas or the hinterland. A standardized World Health Organization STEPwise approach to surveillance questionnaire was adapted and used to obtain information about demographic characteristics, lifestyle, and risk factors. Physical examinations were performed to measure blood pressure, height, weight, and waist circumference. Biochemical analysis of collected blood samples evaluated the levels of glucose, high-density-lipoprotein cholesterol, total cholesterol, and triglycerides. Statistical analysis will be used to identify the burden of modifiable and unmodifiable risk factors in the aforementioned subgroups. Subsequently, tailor-made interventions will be prepared and their effects will be evaluated. Results: The data as collected allow for national inference and valid analysis of the age, sex, and ethnicity subgroups in the Surinamese population. A publication of the basic survey results is anticipated in mid-2015. Secondary results on the effect of targeted lifestyle interventions are anticipated in late 2017. Conclusions: Using the data collected in this study, the national prevalence of NCD risk factors will be approximated and described in a diverse population. This study is an entry point for formulating the structure of NCD prevention and surveillance. UR - http://www.researchprotocols.org/2015/2/e75/ UR - http://dx.doi.org/10.2196/resprot.4205 UR - http://www.ncbi.nlm.nih.gov/pubmed/26085372 ID - info:doi/10.2196/resprot.4205 ER -